Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis
NCT ID: NCT06788535
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-01-14
2026-02-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Single dose, Open label
Open label use of I124-evuzamitide to diagnose cardiac amyloidosis.
I-124 evuzamitide
I-124 evuzamitide, single dose imaging agent, administered intravenously.
Interventions
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I-124 evuzamitide
I-124 evuzamitide, single dose imaging agent, administered intravenously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female ≥18 years of age.
* 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.
* Able to undergo PET/CT imaging as part of the study, including ability to lie supine for approximately 1 hour.
* 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.
* For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Exclusion Criteria
* 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.
* 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.
* Is pregnant or breast-feeding.
* Is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis.
* Has a known allergy to potassium iodide.
* Receiving hemodialysis or peritoneal dialysis.
* eGFR less than 15mL/min/1.73m2.
* Myocardial infarction within three (3) months of screening.
* Has severe claustrophobia or any condition, medial or otherwise, that would prevent completion of the study assessments.
* Has any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the participant.
* Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within seven (7) days prior to I-124 evuzamitide administration.
* Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal T4).
18 Years
ALL
No
Sponsors
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Attralus, Inc.
INDUSTRY
Sharmila Dorbala
OTHER
Responsible Party
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Sharmila Dorbala
Director Nuclear Cardiology
Locations
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Mayo Clinic
Scottsdale, Arizona, United States
City of Hope - Duarte
Duarte, California, United States
University of California
San Francisco, California, United States
Yale Cardiovascular Medicine
New Haven, Connecticut, United States
Cleveland Clinic
Weston, Florida, United States
Northwestern University
Chicago, Illinois, United States
Cook County Health
Chicago, Illinois, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Lukes (CVIT) Saint Luke's Health System
Kansas City, Missouri, United States
Washington University of St. Louis
St Louis, Missouri, United States
Rutgers
New Brunswick, New Jersey, United States
Columbia University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cone Health
Greensboro, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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2024P002136
Identifier Type: -
Identifier Source: org_study_id