Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

July 30, 2025 updated by: Edward J Miller, Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 screening evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-flutemetamol
All clinical trial subjects will receive 18F-flutemetamol
Drug: (18F)Flutemetamol
18F-Flutemetamol binds to β-amyloid plaques and the F-18 isotope produces a positron signal that is detected by a PET scanner. Multiple recent studies have shown that thioflavin-analogue tracers such as 18F-flutemetamol may be able to fulfill the unmet need of elucidating the presence of amyloid deposition in the heart. Because it binds to the beta-pleated motif of the amyloid fibril due to their similarity to the thioflavin structure, 18F-Flutemetamol could potentially be used to image cardiac amyloidosis (CA)
Other Names:
  • Vizamyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time Frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans
6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time Frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans
6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time Frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans
6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time Frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans
6 months
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Time Frame: 6 months
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans
6 months
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
Time Frame: 6 months
As assessed by dynamic cardiac PET between baseline and 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time Frame: 6 months
As determined by ATTR clinical stage baseline and following 6 months of treatment with tafamidis.
6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time Frame: 6 months
As determined by NT-proBNP between baseline and following 6 months of treatment with tafamidis.
6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time Frame: 6 months
As determined by TnT between baseline and following 6 months of treatment with tafamidis.
6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time Frame: 6 months
As determined by echocardiographic wall thickness between baseline and following 6 months of treatment with tafamidis.
6 months
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
Time Frame: 6 months
As determined by global longitudinal strain between baseline and following 6 months of treatment with tafamidis.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Edward J Miller, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Actual)

November 14, 2024

Study Completion (Actual)

November 14, 2024

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000031407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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