COMPLETED

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Talk to us

Conditions

Cardiomyopathies, PrimaryTransthyretin amyloidosis

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Quick Facts

Study Start:2022-08-16
Study Completion:2024-11-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05374564

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Age \> 18 years
  2. * 2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
  3. * 3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
  4. * 4. Stated willingness to comply with all study procedures and availability for the duration of the study
  5. * 5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
  6. * 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. * 1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
  2. * 2. Prior liver or heart transplantation.
  3. * 3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
  4. * 4. Inability to lie flat for 60 minutes in the PET scanner
  5. * 5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
  6. * 6. Pregnancy or lactation
  7. * 7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
  8. * 8. High risk for non-adherence as determined by screening evaluation.

Contacts and Locations

Principal Investigator

Edward J Miller, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Edward J Miller, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-16
Study Completion Date2024-11-14

Study Record Updates

Study Start Date2022-08-16
Study Completion Date2024-11-14

Terms related to this study

Keywords Provided by Researchers

  • Transthyretin amyloidosis

Additional Relevant MeSH Terms

  • Cardiomyopathies, Primary