Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT04410367
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2020-05-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C117460', 'term': 'fluciclovine F-18'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@blueearthDx.com', 'phone': '+44 (0)1865 784 186', 'title': 'Chief Medical Officer', 'organization': 'Blue Earth Diagnostics, Ltd.'}, 'certainAgreement': {'otherDetails': 'Neither the INSTITUTION nor the INVESTIGATOR will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the multi-center clinical trial results; (b) notification by BED that the multi-center clinical trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the multi-center clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety was assessed from the time of 18F-fluciclovine administration until 1 day post18Ffluciclovine administration based on reported adverse events (AEs) and serious adverse events (SAEs); treatment emergent adverse events (TEAE).', 'eventGroups': [{'id': 'EG000', 'title': '18F-Fluciclovine Injection', 'description': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and an evaluable central histopathology report from the sample obtained from the SoC craniotomy.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-Fluciclovine Injection', 'description': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and positive histopathology.'}], 'classes': [{'title': 'Mild or Higher Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Mild or Higher Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Mild or Higher Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '99.8'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '73.8'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '26.2', 'upperLimit': '87.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity.\n\nThree readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth (central histopathological analysis).'}, {'type': 'PRIMARY', 'title': 'Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-Fluciclovine Injection', 'description': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and negative histopathology.'}], 'classes': [{'title': 'Mild or Higher Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.7'}]}]}, {'title': 'Mild or Higher Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.7'}]}]}, {'title': 'Mild or Higher Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '24.7'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '68.4'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '61.4'}]}]}, {'title': 'Moderate or Higher Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.9'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '99.8'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}]}]}, {'title': 'Marked Uptake = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Specificity analysis (%) based on 13 subjects with negative lesions per standard of truth (central histopathological analysis).'}, {'type': 'SECONDARY', 'title': 'Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-Fluciclovine Injection', 'description': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and positive histopathology'}], 'classes': [{'title': 'Quantitative SUV ≥ 4.8 = Positive : Central Reader 1', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Quantitative SUV ≥ 4.8 = Positive : Central Reader 2', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Quantitative SUV ≥ 4.8 = Positive : Central Reader 3', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Dynamic Type 0: Central Reader 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}, {'title': 'Dynamic Type 0 : Central Reader 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}, {'title': 'Dynamic Type 0 : Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}, {'title': 'Dynamic Type I: Central Reader 1', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Dynamic Type I: Central Reader 2', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '99.8'}]}]}, {'title': 'Dynamic Type I: Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type II: Central Reader 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}, {'title': 'Dynamic Type II: Central Reader 2', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}, {'title': 'Dynamic Type II: Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}, {'title': 'Dynamic Type III: Central Reader 1', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '44.5'}]}]}, {'title': 'Dynamic Type III: Central Reader 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}, {'title': 'Dynamic Type III: Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or \\> threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Sensitivity analysis (%) based on 10 subjects with positive lesions per standard of truth.'}, {'type': 'SECONDARY', 'title': 'Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-Fluciclovine Injection', 'description': 'Specificity of 18F fluciclovine PET for detecting recurrent brain metastases based on quantitative and dynamic measures of lesion 18F fluciclovine uptake'}], 'classes': [{'title': 'SUV ≥ 4.8 : Central Reader 1', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}, {'title': 'SUV ≥ 4.8 : Central Reader 2', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}, {'title': 'SUV ≥ 4.8 : Central Reader 3', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}, {'title': 'Dynamic Type 0 : Central Reader 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type 0 : Central Reader 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type 0 : Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type I : Central Reader 1', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '36.0'}]}]}, {'title': 'Dynamic Type I : Central Reader 2', 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '45.5'}]}]}, {'title': 'Dynamic Type I : Central Reader 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24.7'}]}]}, {'title': 'Dynamic Type II : Central Reader 1', 'categories': [{'measurements': [{'value': '92.3', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '99.8'}]}]}, {'title': 'Dynamic Type II : Central Reader 2', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '98.1'}]}]}, {'title': 'Dynamic Type II : Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type III : Central Reader 1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type III : Central Reader 2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}, {'title': 'Dynamic Type III : Central Reader 3', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '75.3', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '60 days', 'description': 'Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV \\< threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative)', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and negative histopathology.'}, {'type': 'SECONDARY', 'title': 'Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-Fluciclovine Injection', 'description': 'Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 2 days post-18F-fluciclovine administration.'}], 'classes': [{'title': 'Subjects reporting at least 1 TEAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Nervous System Disorders (Headache)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.', 'description': 'Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '18F-Fluciclovine Injection', 'description': 'Subjects who have been dosed with 18F-Fluciclovine, have an evaluable on-study PET scan, and an evaluable central histopathology report from the sample obtained from the SoC craniotomy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Underwent 18F-fluciclovine PET', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects with a history of brain metastases previously treated with primary, adjuvant, or repeat (salvage) radiation therapy, with a recent standard of care (SoC) brain magnetic resonance imaging (MRI) found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled.\n\nSubjects were screened between 28Oct2020 and 30Dec2021. Nine clinical research sites in the US participated in the study.', 'preAssignmentDetails': "On-study site investigators prospectively annotated and measured the 'reference lesion' on a postradiation treatment MRI scan and on the SoC MRI brain scan to confirm eligibility. The 'reference lesion' was defined as the lesion which was Equivocal for recurrent metastasis on SoC MRI, Intended for pre-planned SoC craniotomy, and If \\> 1 equivocal lesion was intended for resection, the largest of these lesions."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients', 'description': 'Single intravenous administration of 18F fluciclovine for PET Scan\n\n18F fluciclovine: 18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '11.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', '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': '20', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-10', 'size': 2505795, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-09T11:53', 'hasProtocol': True}, {'date': '2021-07-01', 'size': 1073444, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-09T11:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Positron Emission Tomography (PET) Imaging study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2020-05-27', 'resultsFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-11', 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds', 'timeFrame': '60 days', 'description': 'Sensitivity is calculated as % of participants with positive histopathology who are classified as positive on their 18F fluciclovine PET (i.e. true positive). Each participant had one lesion, therefore results are representative of both subject and lesion level sensitivity.\n\nThree readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. Three different thresholds of 18F fluciclovine uptake were then applied to calculate the sensitivity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. As an example, for calculating sensitivity based on the threshold of Mild or Higher Uptake, all participants with positive histopathology, classified by a reader as having mild, moderate or marked 18F fluciclovine uptake, would be categorized as true positive. This calculation was then repeated on the other two threshold categories, to produce sensitivities at different thresholds.'}, {'measure': 'Specificity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases at Different Visual Thresholds', 'timeFrame': '60 days', 'description': 'Specificity is calculated as the % of participants with negative histopathology who are classified as negative on their 18F fluciclovine PET (i.e. true negative). Each participant had 1 lesion, therefore results are representative of both subject and lesion level specificity. 3 readers evaluated the PET scans to classify 18F fluciclovine uptake in study lesions according to 4 incremental categories: absent, mild, moderate or marked. 3 different thresholds of uptake were then applied to calculate the specificity: Mild or Higher Uptake, Moderate or Higher Uptake, Marked Uptake. Example, for calculating specificity based on the threshold of Moderate or Higher Uptake, all participants with negative histopath, classified by a reader as having absent or mild uptake (i.e. not classified by a reader as having moderate or marked uptake), would be categorized as true negative. This calculation was repeated on the other 2 threshold categories, to produce specificities at different thresholds'}], 'secondaryOutcomes': [{'measure': 'Sensitivity of 18F Fluciclovine PET for Detecting Recurrent Brain Metastases Based on Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake', 'timeFrame': '60 days', 'description': 'Sensitivity calculated as %participants with positive histopath and positive on PET (i.e. true positive). Each participant had 1 lesion, results represent both subject and lesion level sensitivity. Sensitivity is calculated using positive PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Sensitivity calculation: participants with positive histopath and SUV = or \\> threshold are positive on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Sensitivity is calculated for each type of uptake pattern (example: calculating sensitivity based on Type I pattern, participants with positive histopath, classified as Type I, would be categorized as true positive).'}, {'measure': 'Specificity of Different Thresholds of Quantitative and Dynamic Measures of Lesion 18F Fluciclovine Uptake.', 'timeFrame': '60 days', 'description': 'Specificity is calculated as %participants with negative histopath and negative on PET (i.e. true negative). Each participant had 1 lesion, results represent both subject and lesion level specificity. Specificity is calculated using negative PET classified by quantitative and dynamic measures. Quantitative measure is based on lesion standardized uptake value (SUV). Receiver Operating Characteristic (ROC) analysis of all participant lesion SUV was performed. ROC analyses was performed to select a SUV threshold for calculating sensitivity. Specificity calculation: participants with negative histopath, SUV \\< threshold are negative on scan. Dynamic measure: 3 readers evaluated PET scans to classify uptake pattern based on 4 categories: Type 0, Type I, Type II, Type III. Specificity is calculated for each type of uptake pattern (example, calculating specificity based on Type I pattern, participants with negative histopath, classified as Type I, would be categorized as true negative)'}, {'measure': 'Treatment-emergent Adverse Events', 'timeFrame': 'From the time of administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.', 'description': 'Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F fluciclovine until 1 day post-18F-fluciclovine administration.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrent Brain Metastases', 'Diagnostic', 'Positron Emission Tomography (PET) Scan'], 'conditions': ['Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '34081125', 'type': 'DERIVED', 'citation': 'Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n2. Previous history of solid tumor brain metastasis of any origin\n3. Histopathological confirmation of the primary solid tumor or a metastatic site\n4. Previous radiation therapy of brain metastatic lesion(s)\n5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis\n6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for craniotomy\n\nExclusion Criteria:\n\n1\\. Patients with a history of active hematological malignancy'}, 'identificationModule': {'nctId': 'NCT04410367', 'acronym': 'PURSUE', 'briefTitle': 'Study to Establish Image Interpretation Criteria for 18F Fluciclovine PET in Detecting Recurrent Brain Metastases (PURSUE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Blue Earth Diagnostics'}, 'officialTitle': 'An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy', 'orgStudyIdInfo': {'id': 'BED-FLC-219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Single intravenous administration of 18F fluciclovine for PET Scan', 'interventionNames': ['Drug: 18F fluciclovine']}], 'interventions': [{'name': '18F fluciclovine', 'type': 'DRUG', 'otherNames': ['Axumin'], 'description': '18F fluciclovine injection, 185 MegaBecquerel (MBq) (5 Millicurie (mCi)) ± 20%, delivered as an intravenous bolus', 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': "John Wayne Cancer Institute at Providence St. John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Cancer Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '70131', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine Center for Clinical Imaging Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Center for Quantitative Cancer Imaging at Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Eugene Teoh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Blue Earth Diagnostics'}, {'name': 'Rupesh Kotecha, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Blue Earth Diagnostics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Precision For Medicine', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}