Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Description

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.

Conditions

Cardiomyopathies, Primary

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Study Overview

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Study Details

Study overview

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.

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Condition
Cardiomyopathies, Primary
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06520

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

Edward J Miller, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

2025-06