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NCT05374564CompletedPhase 1

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Source: ClinicalTrials.gov · Last updated 3 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (actual)
First submitted
10 May 2022
Start date
16 Aug 2022
Primary completion date
14 Nov 2024
Lead sponsor
Yale University
Diseases
Amyloidosis
NCT number
NCT05374564

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 12
  • From 16 Aug 2022 to the primary completion date, 14 Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 2\. Prior liver or heart transplantation.
  • 5\. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.

Other illness

  • 3\. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
  • 7\. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80

Other

  • 1\. Primary amyloidosis (AL) or secondary amyloidosis (AA).
  • 4\. Inability to lie flat for 60 minutes in the PET scanner
  • 6\. Pregnancy or lactation
  • 8\. High risk for non-adherence as determined by screening evaluation.

Who the study is looking for

  • 1\. Age \> 18 years
  • 2\. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
    • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Yale University
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.