REVEAL - Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis

Korábbi kezelés

• 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 amyloidosis: Patients may enter the screening period of a clinical trial for treatment after the ICF is signed and they are enrolled in this trial, but they may not receive an experimental therapy until after the Day 30 safety follow-up visit in this trial.
• Receiving hemodialysis or peritoneal dialysis.
• Has received heparin or heparin analogs (e.g., enoxaparin, dalteparin, fondaparinux) within 7 days prior to I-124 evuzamitide administration.

Más betegség

• Established diagnosis of cardiac amyloidosis.
• 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 KI.
• Myocardial infarction within 3 months of screening.
• Has severe claustrophobia or any condition, medical 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.
• Known uncorrected thyroid disorders (other than mild elevation of thyroid stimulating hormone with normal thyroxine [T4]).

Laborértékek

• Estimated glomerular filtration rate (eGFR) less than 15 mL/min/1.73 m\^2.

Egyéb

• Established diagnosis of systemic amyloidosis with known organ involvement (e.g., renal AL or ATTR peripheral neuropathy). Participants who are amyloid positive only from peripheral tissue, such as abdominal fat, carpal tunnel tissue, or laminectomy tissue, are allowed as long as they do not have other known organ involvement.
• Is pregnant or breast-feeding.

• 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., echocardiogram [ECHO], cardiac magnetic resonance imaging [CMR], bone-avid tracer cardiac single-photon emission computerized tomography (SPECT), extracardiac biopsy, or endomyocardial biopsy [EMB]). Participants may 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 during the treatment period and for at least 120 days after the last dose of study intervention.