Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Yale University

Status and phase: Enrolling; Phase 1

Conditions: Cardiomyopathies, Primary

Treatments: Drug: (18F)Flutemetamol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05374564

2000031407

Details and patient eligibility

About

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.

Full description

The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

18F-flutemetamol

Experimental group

Description:

All clinical trial subjects will receive 18F-flutemetamol

Treatment:

Drug: (18F)Flutemetamol