Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

Last updated: June 6, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

1

Condition

Circulation Disorders

Treatment

(18F)Flutemetamol

Clinical Study ID

NCT05374564
2000031407
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years
  1. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation) a. Diagnosis of ATTR cardiac amyloidosis by established consensus diagnosticcriteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
  1. Plan for initiation of tafamidis therapy for clinical indications and agree tocontinue tafamidis during the duration of the study.
  1. Stated willingness to comply with all study procedures and availability for theduration of the study
  1. Able to understand and sign the informed consent document after the nature ofthe study has been fully explained.
  1. Women of childbearing potential who are sexually active with a non-sterilizedmale partner and males who are sexually active with a partner of childbearingpotential must agree to use adequate contraception from screening until 30 daysafter the Flutemetamol.

Exclusion

Exclusion Criteria:

  1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
  1. Prior liver or heart transplantation.
  1. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
  1. Inability to lie flat for 60 minutes in the PET scanner
  1. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy,or decline clinical tafamidis treatment.
  1. Pregnancy or lactation
  1. Known allergic reactions to components of the 18F-flutemetamol and/orpolysorbate 80
  1. High risk for non-adherence as determined by screening evaluation.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: (18F)Flutemetamol
Phase: 1
Study Start date:
August 16, 2022
Estimated Completion Date:
June 30, 2025

Study Description

The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.