Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-28 @ 9:42 AM
Study NCT ID:
NCT06788535
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2024-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}, {'id': 'D000686', 'term': 'Amyloidosis'}], 'ancestors': [{'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'I-124 evuzamitide PET/CT imaging will be evaluated by three (3) independent readers who are blinded to all clinical data.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2025-01-16', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Sensitivity', 'timeFrame': 'Up to 60 days after scanning', 'description': 'Assessment of the sensitivity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.'}, {'measure': 'To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis-Specificity', 'timeFrame': 'Up to 60 days after scanning', 'description': 'Assessment of specificity of PET/CT imaging with I-124 evuzamitide for the diagnosis of cardiac amyloidosis based on visual scan interpretation.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Treatment Emergent Adverse Events', 'timeFrame': '30 days after administration of I-124 evuzamitide', 'description': 'Incidence of treatment-emergent Adverse Events (AEs) from Day 1 to Day 30.'}, {'measure': 'To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Creatinine', 'timeFrame': '30 days after administration of I-124 evuzamitide', 'description': 'Change in kidney function from baseline: Creatinine mg/dl'}, {'measure': 'To evaluate the safety of a single intravenous administration of I-124 evuzamitide-eGFR', 'timeFrame': '30 days after administration of I-124 evuzamitide', 'description': 'Change in kidney function from baseline: eGFR ml/min/1.73 m2'}, {'measure': 'To evaluate the safety of a single intravenous administration of I-124 evuzamitide-Liver function.', 'timeFrame': '30 days after administration of I-124 evuzamitide', 'description': 'Change in liver function from baseline LDH units per liter; Alkaline phosphatase units per liter; SGOT units per liter; SGPT units per liter'}, {'measure': 'To evaluate the safety of a single intravenous administration of I-124 evuzamitide.', 'timeFrame': '30 days after administration of I-124 evuzamitide', 'description': 'Change in pregnancy test from baseline Pregnancy testing beta HCG serum testing negative or positive'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyloid Light Chain (AL)', 'Cardiac Amyloidosis', 'Amyloidosis', 'Amyloid Transthyretin (ATTR)', 'Transthyretin (TTR)', 'REVEAL', 'PET Imaging'], 'conditions': ['Cardiac Amyloidosis']}, 'referencesModule': {'references': [{'pmid': '37940323', 'type': 'RESULT', 'citation': 'Wall JS, Martin EB, Lands R, Ramchandren R, Stuckey A, Heidel RE, Whittle B, Powell D, Richey T, Williams AD, Foster JS, Guthrie S, Kennel SJ. Cardiac Amyloid Detection by PET/CT Imaging of Iodine (124I) Evuzamitide (124I-p5+14): A Phase 1/2 Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1433-1448. doi: 10.1016/j.jcmg.2023.08.009.'}, {'pmid': '37676210', 'type': 'RESULT', 'citation': 'Clerc OF, Cuddy SAM, Robertson M, Vijayakumar S, Neri JC, Chemburkar V, Kijewski MF, Di Carli MF, Bianchi G, Falk RH, Dorbala S. Cardiac Amyloid Quantification Using 124I-Evuzamitide (124I-P5+14) Versus 18F-Florbetapir: A Pilot PET/CT Study. JACC Cardiovasc Imaging. 2023 Nov;16(11):1419-1432. doi: 10.1016/j.jcmg.2023.07.007. Epub 2023 Sep 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 3, open label, single dose imaging study is to evaluate the efficacy and safety of I-124 evuzamitide (radioactive dye) for diagnosing Cardiac Amyloidosis in participants with suspected Cardiac Amyloidosis. The imaging test that will be used in this study is a Positron Emission Tomography Computed Tomography (PET/CT) scan.', 'detailedDescription': 'This Phase 3, open label, single dose study will evaluate the efficacy and safety of I-124 evuzamitide when administered as a single dose prior to a PET/CT scan. Participants will be in the study for up to 60 days and approximately 200 participants with suspected Cardiac Amyloidosis will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understands the study procedures and can give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Male or female ≥18 years of age.\n* Is suspected of having cardiac amyloidosis and is undergoing or will undergo a diagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, bone avid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.). Participants can be enrolled before or during their diagnostic evaluation for cardiac amyloidosis.\n* Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\<1% per year during the treatment period and for at least 30 days after administration of I-124 evuzamitide.\n* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Established diagnosis of cardiac amyloidosis.\n* Established diagnosis of systemic amyloidosis (e.g., renal AL or ATTR peripheral neuropathy) without known cardiac involvement. Participants who are amyloid positive only with carpal tunnel tissue or laminectomy are allowed as long as they do not have other known organ involvement.\n* Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinical trial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL and ATTR: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and participant is enrolled in this trial but may not receive an experimental therapy until after the Day 30 safety follow-up visit in this trial.\n* Is pregnant or breast-feeding.\n* Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.\n* Has a known allergy to potassium iodide.\n* Receiving hemodialysis or peritoneal dialysis.\n* eGFR less than 15mL/min/1.73m2.\n* Myocardial infarction within three (3) months of screening.\n* Has severe claustrophobia or any condition, medial or otherwise, that would prevent completion of the study assessments.\n* Has any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the participant.\n* Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to I-124 evuzamitide administration.\n* Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal T4).'}, 'identificationModule': {'nctId': 'NCT06788535', 'acronym': 'REVEAL', 'briefTitle': 'Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'A Phase 3, Open-Label, Multicenter Study of I-124 Evuzamitide as an Imaging Agent for the Diagnosis of Cardiac Amyloidosis Using Positron Emission Tomography Computed Tomography (PET/CT)', 'orgStudyIdInfo': {'id': '2024P002136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose, Open label', 'description': 'Open label use of I124-evuzamitide to diagnose cardiac amyloidosis.', 'interventionNames': ['Drug: I-124 evuzamitide']}], 'interventions': [{'name': 'I-124 evuzamitide', 'type': 'DRUG', 'otherNames': ['AT-01'], 'description': 'I-124 evuzamitide, single dose imaging agent, administered intravenously.', 'armGroupLabels': ['Single dose, Open label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope - Duarte', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cardiovascular Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cook County Health', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "St. Lukes (CVIT) Saint Luke's Health System", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Cone Health', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharmila Dorbala', 'class': 'OTHER'}, 'collaborators': [{'name': 'Attralus, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director Nuclear Cardiology', 'investigatorFullName': 'Sharmila Dorbala', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}