Using a special imaging technique to assess heart disease in patients with transthyretin amyloidosis

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

This study is testing a special imaging technique to see if it can help doctors better understand heart disease in patients with transthyretin amyloidosis who are being treated with tafamidis.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT05374564 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of 18F-flutemetamol PET imaging in assessing cardiac amyloidosis, specifically transthyretin cardiac amyloidosis (ATTR-CA). It will compare baseline and six-month follow-up imaging results in 12 patients undergoing tafamidis treatment. The study will analyze changes in disease burden through quantitative cardiac PET metrics and correlate these findings with clinical and echocardiographic features. The goal is to establish a novel application of this imaging technique for better management of ATTR-CA.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with transthyretin cardiac amyloidosis and planning to start tafamidis therapy.

Not a fit: Patients with primary or secondary amyloidosis other than transthyretin amyloidosis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new method for monitoring disease progression and treatment response in patients with transthyretin cardiac amyloidosis.

How similar studies have performed: While the use of 18F-flutemetamol is established in Alzheimer's imaging, its application in cardiac amyloidosis is novel and has not been extensively tested in prior studies.

Eligibility 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.

Where this trial is running

New Haven, Connecticut

• Yale University — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Edward J Miller, MD — Yale University
• Study coordinator: Maxime Oriol, BS

Conditions: Cardiomyopathies, Primary, Transthyretin amyloidosis