Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

Summary

18F-Flutemetamol (Vizamyl) is a radioactive diagnostic agent indicated and FDA-approved for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) or other causes of cognitive decline. This study is designed to evaluate a novel use for 18F-Flutemetamol in cardiac amyloidosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Flutemetamol

Criteria

Inclusion Criteria:

• 1. Age > 18 years

• 2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)

a. Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)

• 3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.

• 4. Stated willingness to comply with all study procedures and availability for the duration of the study

• 5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.

• 6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.

Exclusion Criteria:

• 1. Primary amyloidosis (AL) or secondary amyloidosis (AA).

• 2. Prior liver or heart transplantation.

• 3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year

• 4. Inability to lie flat for 60 minutes in the PET scanner

• 5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.

• 6. Pregnancy or lactation

• 7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80

• 8. High risk for non-adherence as determined by screening evaluation.