CompletedPhase 1

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

United States12 participantsStarted 2022-08-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 scree…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers

Timeframe: 6 months

Trial details

NCT IDNCT05374564

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-14

View on ClinicalTrials.gov More Cardiomyopathies, Primary trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

Timeframe: 6 months

Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers

Timeframe: 6 months