Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Launched by SHARMILA DORBALA · Jan 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method using a radioactive dye called I-124 evuzamitide to help diagnose a condition known as Cardiac Amyloidosis, which affects the heart. The study will involve participants who are suspected of having this condition and will use a special type of scan called a PET/CT to see how well this dye works in identifying the disease. The trial is currently recruiting participants aged 18 and older of all genders, who are willing to undergo a thorough diagnostic evaluation for cardiac amyloidosis.

To participate, individuals must be able to understand and agree to the study procedures, and they should not already have a confirmed diagnosis of cardiac amyloidosis. Participants will need to lie still for about an hour during the imaging process. It’s important to note that those who are pregnant, breastfeeding, or have certain medical conditions will not be eligible. Throughout the study, participants will receive careful monitoring to ensure their safety. Overall, this trial aims to improve the way doctors diagnose cardiac amyloidosis, which could lead to better treatment options in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • 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 cardiac amyloidosis.
• • 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).