Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 9:01 AM
Study NCT ID:
NCT05235269
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2021-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sstephens@attralus.com', 'phone': '321-228-7400', 'title': 'Scott Stephens, Senior Director Clinical Operations', 'organization': 'Attralus'}, 'certainAgreement': {'otherDetails': 'All study data will be regarded as confidential until analysis and review by the Sponsor or its designee and the Investigator(s) are completed. The results of the study may be published or presented at scientific meetings by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor. Prior to publication or presentation, a copy of the final text should be forwarded by the Investigator(s) to the Sponsor or its designee, for comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Time of informed consent until the end of the study (up to 14 weeks)', 'eventGroups': [{'id': 'EG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 13, 'seriousNumAtRisk': 33, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site bruised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysponea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood lactic acid increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Heart - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.58', 'groupId': 'OG000', 'lowerLimit': '-31.4', 'upperLimit': '45.8'}]}]}, {'title': 'Heart - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.50', 'groupId': 'OG000', 'lowerLimit': '-31.3', 'upperLimit': '45.5'}]}]}, {'title': 'Heart - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.97', 'groupId': 'OG000', 'lowerLimit': '-28.7', 'upperLimit': '40.2'}]}]}, {'title': 'Kidney - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.28', 'groupId': 'OG000', 'lowerLimit': '-34.2', 'upperLimit': '51.9'}]}]}, {'title': 'Kidney - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.46', 'groupId': 'OG000', 'lowerLimit': '-22.2', 'upperLimit': '28.5'}]}]}, {'title': 'Kidney - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.18', 'groupId': 'OG000', 'lowerLimit': '-32.4', 'upperLimit': '48.0'}]}]}, {'title': 'Liver - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.38', 'groupId': 'OG000', 'lowerLimit': '-31.1', 'upperLimit': '45.1'}]}]}, {'title': 'Liver - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.54', 'groupId': 'OG000', 'lowerLimit': '-16.1', 'upperLimit': '19.2'}]}]}, {'title': 'Liver - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.97', 'groupId': 'OG000', 'lowerLimit': '-19.1', 'upperLimit': '23.7'}]}]}, {'title': 'Spleen - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.69', 'groupId': 'OG000', 'lowerLimit': '-20.6', 'upperLimit': '26.0'}]}]}, {'title': 'Spleen - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.64', 'groupId': 'OG000', 'lowerLimit': '-22.5', 'upperLimit': '29.1'}]}]}, {'title': 'Spleen - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.39', 'groupId': 'OG000', 'lowerLimit': '-20.1', 'upperLimit': '25.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Week 6', 'description': 'Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantitation (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nwCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Smaller values of wCV represent better agreement. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.\n\nOnly images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.', 'unitOfMeasure': 'coefficient of variation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.'}, {'type': 'PRIMARY', 'title': 'Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Heart - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.06', 'groupId': 'OG000', 'lowerLimit': '-28.8', 'upperLimit': '40.5'}]}]}, {'title': 'Heart - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.57', 'groupId': 'OG000', 'lowerLimit': '-26.2', 'upperLimit': '35.5'}]}]}, {'title': 'Heart - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.21', 'groupId': 'OG000', 'lowerLimit': '-19.6', 'upperLimit': '24.5'}]}]}, {'title': 'Kidney - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.82', 'groupId': 'OG000', 'lowerLimit': '-28.4', 'upperLimit': '39.7'}]}]}, {'title': 'Kidney - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.95', 'groupId': 'OG000', 'lowerLimit': '-23.1', 'upperLimit': '30.1'}]}]}, {'title': 'Kidney - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.88', 'groupId': 'OG000', 'lowerLimit': '-30.2', 'upperLimit': '43.4'}]}]}, {'title': 'Liver - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.68', 'groupId': 'OG000', 'lowerLimit': '-22.6', 'upperLimit': '29.2'}]}]}, {'title': 'Liver - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.37', 'groupId': 'OG000', 'lowerLimit': '-20.0', 'upperLimit': '25.0'}]}]}, {'title': 'Liver - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.32', 'groupId': 'OG000', 'lowerLimit': '-19.9', 'upperLimit': '24.8'}]}]}, {'title': 'Spleen - Reader 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.47', 'groupId': 'OG000', 'lowerLimit': '-27.8', 'upperLimit': '38.5'}]}]}, {'title': 'Spleen - Reader 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.48', 'groupId': 'OG000', 'lowerLimit': '-27.8', 'upperLimit': '38.5'}]}]}, {'title': 'Spleen - Reader 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.84', 'groupId': 'OG000', 'lowerLimit': '-28.4', 'upperLimit': '39.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Week 6', 'description': 'Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nwCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.\n\nOnly images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.', 'unitOfMeasure': 'coefficient of variation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.'}, {'type': 'PRIMARY', 'title': 'Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Heart - Day 1', 'categories': [{'measurements': [{'value': '0.903', 'groupId': 'OG000', 'lowerLimit': '0.796', 'upperLimit': '0.955'}]}]}, {'title': 'Heart - Week 6', 'categories': [{'measurements': [{'value': '0.955', 'groupId': 'OG000', 'lowerLimit': '0.903', 'upperLimit': '0.980'}]}]}, {'title': 'Kidney - Day 1', 'categories': [{'measurements': [{'value': '0.973', 'groupId': 'OG000', 'lowerLimit': '0.940', 'upperLimit': '0.988'}]}]}, {'title': 'Kidney - Week 6', 'categories': [{'measurements': [{'value': '0.964', 'groupId': 'OG000', 'lowerLimit': '0.922', 'upperLimit': '0.984'}]}]}, {'title': 'Liver - Day 1', 'categories': [{'measurements': [{'value': '0.971', 'groupId': 'OG000', 'lowerLimit': '0.937', 'upperLimit': '0.987'}]}]}, {'title': 'Liver - Week 6', 'categories': [{'measurements': [{'value': '0.975', 'groupId': 'OG000', 'lowerLimit': '0.946', 'upperLimit': '0.989'}]}]}, {'title': 'Spleen - Day 1', 'categories': [{'measurements': [{'value': '0.991', 'groupId': 'OG000', 'lowerLimit': '0.979', 'upperLimit': '0.996'}]}]}, {'title': 'Spleen - Week 6', 'categories': [{'measurements': [{'value': '0.996', 'groupId': 'OG000', 'lowerLimit': '0.992', 'upperLimit': '0.998'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Week 6', 'description': "Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.\n\nReader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.'}, {'type': 'PRIMARY', 'title': 'Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Heart - Day 1', 'categories': [{'measurements': [{'value': '0.960', 'groupId': 'OG000', 'lowerLimit': '0.913', 'upperLimit': '0.982'}]}]}, {'title': 'Heart - Week 6', 'categories': [{'measurements': [{'value': '0.987', 'groupId': 'OG000', 'lowerLimit': '0.970', 'upperLimit': '0.994'}]}]}, {'title': 'Kidney - Day 1', 'categories': [{'measurements': [{'value': '0.994', 'groupId': 'OG000', 'lowerLimit': '0.986', 'upperLimit': '0.997'}]}]}, {'title': 'Kidney - Week 6', 'categories': [{'measurements': [{'value': '0.991', 'groupId': 'OG000', 'lowerLimit': '0.980', 'upperLimit': '0.996'}]}]}, {'title': 'Liver - Day 1', 'categories': [{'measurements': [{'value': '0.993', 'groupId': 'OG000', 'lowerLimit': '0.984', 'upperLimit': '0.997'}]}]}, {'title': 'Liver - Week 6', 'categories': [{'measurements': [{'value': '0.990', 'groupId': 'OG000', 'lowerLimit': '0.978', 'upperLimit': '0.995'}]}]}, {'title': 'Spleen - Day 1', 'categories': [{'measurements': [{'value': '0.997', 'groupId': 'OG000', 'lowerLimit': '0.992', 'upperLimit': '0.998'}]}]}, {'title': 'Spleen - Week 6', 'categories': [{'measurements': [{'value': '0.999', 'groupId': 'OG000', 'lowerLimit': '0.997', 'upperLimit': '0.999'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Week 6', 'description': "Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.\n\nReader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Image Evaluable Set was defined as all participants who underwent PET/CT scans on both Day 1 and 6 to 8 weeks after Day 1 and who had evaluable images at both time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With At Least 1 Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through the end of the study (up to 14 weeks)', 'description': 'TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of treatment. Adverse events (AEs) that occurred after the treatment start date, occurred on the treatment start date with a time that was equal to or after treatment start time, or that had a missing AE start date were categorized as treatment emergent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Chemistry (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Calcium - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.1079', 'groupId': 'OG000'}]}]}, {'title': 'Calcium - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '1.1013', 'groupId': 'OG000'}]}]}, {'title': 'Carbon Dioxide - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Carbon Dioxide - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'Chloride - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Chloride - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Glucose - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3515', 'spread': '1.34157', 'groupId': 'OG000'}]}]}, {'title': 'Glucose - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1310', 'spread': '1.63653', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0025', 'spread': '0.16570', 'groupId': 'OG000'}]}]}, {'title': 'Phosphate - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0229', 'spread': '0.16665', 'groupId': 'OG000'}]}]}, {'title': 'Potassium - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.462', 'groupId': 'OG000'}]}]}, {'title': 'Potassium - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Sodium - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.32', 'groupId': 'OG000'}]}]}, {'title': 'Sodium - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '2.71', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2116', 'spread': '1.81616', 'groupId': 'OG000'}]}]}, {'title': 'Urea Nitrogen - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0429', 'spread': '2.17049', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of mmol/L', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Chemistry (Umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Bilirubin - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0136', 'spread': '4.00446', 'groupId': 'OG000'}]}]}, {'title': 'Bilirubin - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2315', 'spread': '2.44487', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.24', 'spread': '18.541', 'groupId': 'OG000'}]}]}, {'title': 'Creatinine - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '14.430', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of umol/L', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Chemistry (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Albumin - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Albumin - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Protein - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.22', 'groupId': 'OG000'}]}]}, {'title': 'Protein - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '3.61', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of g/L', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Chemistry (IU/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Alanine Aminotransferase - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.54', 'groupId': 'OG000'}]}]}, {'title': 'Alanine Aminotransferase - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '8.03', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '13.20', 'groupId': 'OG000'}]}]}, {'title': 'Alkaline Phosphatase - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '12.46', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.78', 'groupId': 'OG000'}]}]}, {'title': 'Aspartate Aminotransferase - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '5.64', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '55.16', 'groupId': 'OG000'}]}]}, {'title': 'Lactate Dehydrogenase - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '49.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of IU/L', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Basophils/Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Basophils/Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils/Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils/Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes/Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '6.62', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes/Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '6.32', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes/Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.57', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes/Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.68', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '9.62', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils/Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '9.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of % of WBC count', 'unitOfMeasure': '% of WBC count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Hematology (10^9 Cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Basophils - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.051', 'groupId': 'OG000'}]}]}, {'title': 'Basophils - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.057', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.085', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.108', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '1.961', 'groupId': 'OG000'}]}]}, {'title': 'Leukocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '2.115', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.314', 'groupId': 'OG000'}]}]}, {'title': 'Lymphocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.287', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.208', 'groupId': 'OG000'}]}]}, {'title': 'Monocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.156', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.22', 'spread': '1.984', 'groupId': 'OG000'}]}]}, {'title': 'Neutrophils - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '2.028', 'groupId': 'OG000'}]}]}, {'title': 'Platelets - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '35.43', 'groupId': 'OG000'}]}]}, {'title': 'Platelets - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '37.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of 10\\^9 cells/L', 'unitOfMeasure': '10^9 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Hematology (10^12 Cells/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Erythrocytes - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.2684', 'groupId': 'OG000'}]}]}, {'title': 'Erythrocytes - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.055', 'spread': '0.2600', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of 10\\^12 cells/L', 'unitOfMeasure': '10^12 cells/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Hematology (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Hemoglobin - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '8.60', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '8.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Change from baseline in hematology clinical laboratory values with units of g/L', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Hematocrit - Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '2.554', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit - Safety Follow-up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.54', 'spread': '2.521', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from Baseline in hematology clinical laboratory values with units of % of total blood cell count', 'unitOfMeasure': '% of total blood cell count', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Blood Pressure (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Systolic Blood Pressure - Day 1 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '9.21', 'groupId': 'OG000'}]}]}, {'title': 'Systolic Blood Pressure - Week 6 Pre-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.9', 'spread': '15.97', 'groupId': 'OG000'}]}]}, {'title': 'Systolic Blood Pressure - Week 6 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.5', 'spread': '16.98', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure - Day 1 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '6.65', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure - Week 6 Pre-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '11.01', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic Blood Pressure - Week 6 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '11.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post-administration and Week 6 pre-administration and post-administration', 'description': 'Changes from baseline in blood pressure measurements with units of mmHg', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Signs - Heart Rate (Beats/Min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Heart Rate - Day 1 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '7.93', 'groupId': 'OG000'}]}]}, {'title': 'Heart Rate - Week 6 Pre-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '7.37', 'groupId': 'OG000'}]}]}, {'title': 'Heart Rate - Week 6 Post-Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '7.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 post-administration and Week 6 pre-administration and post-administration', 'description': 'Changes from baseline in heart rate measurements with units of beats/min', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Anti-Drug Antibodies (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'classes': [{'title': 'Negative for ADA at Screening and negative for ADA post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Negative for ADA at Screening and positive for ADA post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-dose at Week 6 or Safety Follow-up 2 (28 days after Week 6)', 'description': 'Changes from baseline in ADA', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set was defined as all participants who received any amount of 124I-AT-01.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Day 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}, {'type': 'Week 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Safety Follow-up 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Safety Follow-up 2 (EOS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant elected to drop out (i.e., not undergo second scan) but did not withdraw consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol-specified withdrawal criterion met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Of the initial 34 participants screened, 32 participants met inclusion criteria and were enrolled for treatment. Two participants were screen failures, one of whom was re-screened and subsequently enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '124I-AT-01', 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '10.86', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-08', 'size': 746277, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-29T10:19', 'hasProtocol': True}, {'date': '2022-12-16', 'size': 941044, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-31T10:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, no placebo, no comparator'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2021-12-10', 'resultsFirstSubmitDate': '2025-07-31', 'studyFirstSubmitQcDate': '2022-02-01', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-29', 'studyFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'timeFrame': 'Day 1 and Week 6', 'description': 'Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantitation (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nwCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Smaller values of wCV represent better agreement. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.\n\nOnly images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.'}, {'measure': 'Within-Participant Coefficient of Variation [wCV] Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'timeFrame': 'Day 1 and Week 6', 'description': 'Between-visit repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nwCV with its associated 95% RC provides guidance on the level of change in organ-specific quantitation of radiotracer uptake that needs to be observed to be confident that a true change in uptake has occurred. Computation of wCV and associated RCs in addition to the two-sided 95% CI is described in the SAP.\n\nOnly images from participants/organs with positive uptake were included. RCs between visits were calculated using the difference of the log of the average of the 2 reads for a reader at Day 1 and the log of the average of the 2 reads for the same reader at Week 6. The 95% RCs were calculated on the log-transformed data and exponentiated to determine the limits in percentages.'}, {'measure': 'Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVmax) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'timeFrame': 'Day 1 and Week 6', 'description': "Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVmax) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.\n\nReader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP."}, {'measure': 'Intraclass Correlation Coefficient (ICC) Associated With the Quantification (SUVpeak) of Radioactivity Associated With Organ-Level Radiotracer Uptake', 'timeFrame': 'Day 1 and Week 6', 'description': "Repeatability of organ-specific (heart, kidney, liver, spleen) quantification (SUVpeak) of radiotracer uptake following PET/CT imaging of 124I-AT-01 in participants with AL or ATTR systemic amyloidosis was assessed.\n\nICC assesses the consistency or reproducibility of measurements made by the 3 readers measuring the same participant images.\n\nReader results are the average of the reader's 2 reads for the specific visit. A two-way mixed effects model with absolute agreement type for a single rater/measurement was used to calculate the ICC. The ICC coefficient is the ratio of the between-cluster variance to the total variance (denoted as r in the SAP). Fisher's z-transformation was used to calculate the 95% confidence intervals. A two-sided 95% CI is computed based upon the formulary provided in the SAP."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With At Least 1 Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 through the end of the study (up to 14 weeks)', 'description': 'TEAEs were defined as events that were newly reported or reported to worsen in severity after the start of treatment. Adverse events (AEs) that occurred after the treatment start date, occurred on the treatment start date with a time that was equal to or after treatment start time, or that had a missing AE start date were categorized as treatment emergent.'}, {'measure': 'Clinical Laboratory Values - Chemistry (mmol/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of mmol/L'}, {'measure': 'Clinical Laboratory Values - Chemistry (Umol/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of umol/L'}, {'measure': 'Clinical Laboratory Values - Chemistry (g/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of g/L'}, {'measure': 'Clinical Laboratory Values - Chemistry (IU/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in chemistry clinical laboratory values with units of IU/L'}, {'measure': 'Clinical Laboratory Values - Hematology (% of White Blood Cell [WBC] Count)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of % of WBC count'}, {'measure': 'Clinical Laboratory Values - Hematology (10^9 Cells/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of 10\\^9 cells/L'}, {'measure': 'Clinical Laboratory Values - Hematology (10^12 Cells/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from baseline in hematology clinical laboratory values with units of 10\\^12 cells/L'}, {'measure': 'Clinical Laboratory Values - Hematology (g/L)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Change from baseline in hematology clinical laboratory values with units of g/L'}, {'measure': 'Clinical Laboratory Values - Hematology (% of Total Blood Cell Count)', 'timeFrame': 'At Week 6 and Safety Follow-up 1 (24 to 48 hours after Week 6)', 'description': 'Changes from Baseline in hematology clinical laboratory values with units of % of total blood cell count'}, {'measure': 'Change From Baseline in Vital Signs - Blood Pressure (mmHg)', 'timeFrame': 'Day 1 post-administration and Week 6 pre-administration and post-administration', 'description': 'Changes from baseline in blood pressure measurements with units of mmHg'}, {'measure': 'Change From Baseline in Vital Signs - Heart Rate (Beats/Min)', 'timeFrame': 'Day 1 post-administration and Week 6 pre-administration and post-administration', 'description': 'Changes from baseline in heart rate measurements with units of beats/min'}, {'measure': 'Change From Baseline in Anti-Drug Antibodies (ADA)', 'timeFrame': 'Post-dose at Week 6 or Safety Follow-up 2 (28 days after Week 6)', 'description': 'Changes from baseline in ADA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyloid light chain (AL)', 'Amyloid Transthyretin Systemic Amyloidosis (ATTR)'], 'conditions': ['Amyloidosis']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the repeatability of organ-specific quantitation of radiotracer uptake following Positron Emission Tomography/Computed Tomography (PET/CT) imaging of AT- 01 in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis.', 'detailedDescription': 'This is a multicenter, open label, single arm study in subjects with amyloid light chain (AL) or amyloid transthyretin (ATTR) systemic amyloidosis with visceral amyloid deposits. This study consists of a screening period of up to 30 days; two one-day treatment periods (Day 1 and Week 6); a safety follow-up 24-48 hours after the second administration of 124I AT-01, and a safety follow-up visit 28 days after the second administration of 124I-AT-01.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understands the study procedures and is capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n2. Male or female ≥18 years of age.\n3. For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of \\<1% per year during the treatment period and for at least 90 days after the last dose of 124I-AT-01.\n\n 1. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state, and has not undergone surgical sterilization.\n 2. Examples of contraceptive methods with a failure rate of \\<1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n 3. Contraception methods that do not result in a failure rate of \\<1% per year such as cap, diaphragm, or sponge with spermicide, or male or female condom with or without spermicide, are not acceptable.\n 4. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n4. For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm, as defined below:\n\n a) With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\<1% per year during the treatment period and for at least 120 days (a spermatogenesis cycle) after the last dose of study intervention. Men must refrain from donating sperm during this same time period.\n5. Able to undergo two PET/CT scans as part of the study, including ability to lie supine for up to 1 hour.\n6. Has a history of AL or ATTR systemic amyloidosis with at least one organ with clinically demonstrable amyloid involvement defined by:\n\n 1. AL systemic amyloidosis: Positive tissue biopsy for AL amyloid, and achieved a hematologic very good partial response or complete response based on their most recent assessment, and at least one of the following: 1) Organ biopsy positive for amyloid, or 2) Natriuretic peptide (NT-proBNP) \\>650 pg/mL, or 3) left ventricle septal wall thickness \\>12 mm by echocardiogram or cardiac magnetic resonance (CMR), or 4) 24-hour urine protein \\>500 mg, or 5) Urine albumin-to-creatinine ratio \\>300 mg/g\n 2. ATTR (wild type or variant) systemic amyloidosis: Positive cardiac biopsy for ATTR amyloid, or at least two of the following: 1) Positive extracardiac tissue biopsy for ATTR amyloid or positive transthyretin gene mutation associated with amyloid, or 2) left ventricle septal wall thickness \\>12 mm by echocardiogram or CMR, or 3) pyrophosphate (PYP) scintigraphy with myocardial uptake ≥grade 2.\n\nExclusion Criteria\n\n1. Is pregnant or breast-feeding.\n2. Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.\n3. Has received in the last 6 months or are currently receiving treatment with anti-amyloid monoclonal antibody therapy or are expected to begin treatment prior to completing this study.\n4. Has received heparin or heparin analogs within 7 days of Day 1.\n5. Has a significant co-morbidity (e.g., Easter Cooperative Oncology Group (ECOG) score of 3 or greater), New York Heart Association (NYHA) Class IV heart failure, uncontrolled infection, or other ongoing serious illness.\n6. Has active thyroid disease.\n7. Has a known allergy to potassium iodine treatment.\n8. Is receiving hemodialysis or peritoneal dialysis.\n9. Has severe claustrophobia that would prevent completion of the PET/CT imaging protocol.\n10. Has received an investigational agent within five half-lives of the agent or 30 days, whichever is longer, prior to Screening.\n11. Has any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.'}, 'identificationModule': {'nctId': 'NCT05235269', 'acronym': 'AT01-001', 'briefTitle': 'A Study to Evaluate Organ Level Uptake Repeatability of 124I AT-01 in Subjects With Systemic Amyloidosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Attralus, Inc.'}, 'officialTitle': 'A Multicenter, Open-label, Single-arm, Phase 2 Study to Evaluate Safety and Organ Uptake Quantitation Repeatability of 124I AT-01 Using Positron Emission Tomography/X-ray Computed Tomography (PET/CT) in Subjects With Systemic Amyloidosis', 'orgStudyIdInfo': {'id': 'AT01--001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single arm', 'description': '124I-AT-01', 'interventionNames': ['Drug: 124I-AT-01']}], 'interventions': [{'name': '124I-AT-01', 'type': 'DRUG', 'otherNames': ['AT-01', 'I124-AT-01'], 'description': 'All participants received 1 mCi 124I-AT-01 on Day 1 and at Week 6 via IV infusion over 2-5 minutes or slow IV bolus at 1 mL/5 seconds.', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'PET/CT Imaging of Berkeley', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Northern California PET Imaging Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95128', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'PET/CT Imaging of San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}], 'overallOfficials': [{'name': 'Gregory M. Bell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Attralus, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Attralus, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}