Phase
Condition
Amyloidosis
Treatment
I-124 evuzamitide
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Understands the study procedures and can give signed informed consent which includescompliance with the requirements and restrictions listed in the informed consentform (ICF) and in this protocol.
Male or female ≥18 years of age.
Is suspected of having cardiac amyloidosis and is undergoing or will undergo adiagnostic evaluation for cardiac amyloidosis (e.g., echocardiography, CMR, boneavid tracer cardiac SPECT, extracardiac or endomyocardial biopsy, etc.).Participants can be enrolled before or during their diagnostic evaluation forcardiac amyloidosis.
Able to undergo PET/CT imaging as part of the study, including ability to lie supinefor approximately 1 hour.
For women of childbearing potential: agreement to remain abstinent (refrain fromheterosexual intercourse) or use contraceptive methods that result in a failure rateof <1% per year during the treatment period and for at least 30 days afteradministration of I-124 evuzamitide.
For men: agreement to remain abstinent or use contraceptive measures and agreementto refrain from donating sperm
Exclusion
Exclusion Criteria:
Established diagnosis of cardiac amyloidosis.
Established diagnosis of systemic amyloidosis (e.g., renal AL or ATTR peripheralneuropathy) without known cardiac involvement. Participants who are amyloid positiveonly with carpal tunnel tissue or laminectomy are allowed as long as they do nothave other known organ involvement.
Receiving therapy with an approved treatment (e.g., tafamadis) or in a clinicaltrial for treatment for ATTR cardiac amyloidosis at time of enrollment. For AL andATTR: Patients may enter the screening period of a clinical trial for treatmentafter the ICF is signed and participant is enrolled in this trial but may notreceive an experimental therapy until after the Day 30 safety follow-up visit inthis trial.
Is pregnant or breast-feeding.
Is mentally or legally incapacitated, has significant emotional problems at the timeof 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 preventcompletion of the study assessments.
Has any illness that, in the opinion of the investigator, might confound the resultsof 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 thyroidstimulating hormone with normal T4).
Study Design
Study Description
Connect with a study center
City of Hope - Duarte
Duarte, California 91010
United StatesSite Not Available
Yale Cardiovascular Medicine
New Haven, Connecticut 06520
United StatesSite Not Available
Cook County Health
Chicago, Illinois 60612
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
St. Lukes (CVIT) Saint Luke's Health System
Kansas City, Missouri 64111
United StatesSite Not Available
Washington University of St. Louis
St. Louis, Missouri 63110
United StatesSite Not Available
Columbia University
New York, New York 10032
United StatesSite Not Available
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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