← Back to Search

Diagnostic Agent

18F-Flutemetamol PET Imaging for Cardiomyopathy

Phase 1
Recruiting
Led By Edward J Miller, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study
Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation) by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new use for 18F-Flutemetamol to diagnose cardiac amyloidosis, a condition linked to cognitive decline.

Who is the study for?
This trial is for adults over 18 with ATTR cardiac amyloidosis, who are starting tafamidis therapy and can commit to the study duration. Participants must be able to lie flat for an hour and use contraception if of childbearing potential. Those with other types of amyloidosis, past transplants, active cancers, or known allergies to the test drug's components cannot join.Check my eligibility
What is being tested?
(18F)Flutemetamol (Vizamyl), a radioactive agent used in brain PET scans for Alzheimer's diagnosis, is being tested for its novel application in detecting heart issues related to ATTR cardiomyopathy using PET imaging technology.See study design
What are the potential side effects?
While specific side effects are not listed here, as a radioactive diagnostic agent used in PET imaging, potential risks may include allergic reactions and exposure to radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to start and continue tafamidis therapy for the study duration.
Select...
I have been diagnosed with ATTR cardiac amyloidosis.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
Secondary outcome measures
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

Side effects data

From 2011 Phase 3 trial • 218 Patients • NCT01265394
7%
General Disorders and Administration Site Conditions
6%
Vascular System Disorders
6%
Vascular System Disorders-Flushing
5%
Gastrointestinal disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
(18F) Flutemetamol

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-flutemetamolExperimental Treatment1 Intervention
All clinical trial subjects will receive 18F-flutemetamol

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,851 Previous Clinical Trials
2,738,354 Total Patients Enrolled
3 Trials studying Cardiomyopathies
5,150 Patients Enrolled for Cardiomyopathies
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,973 Total Patients Enrolled
23 Trials studying Cardiomyopathies
5,449 Patients Enrolled for Cardiomyopathies
Edward J Miller, MDPrincipal InvestigatorYale University

Media Library

(18F)Flutemetamol (Diagnostic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05374564 — Phase 1
Cardiomyopathies Research Study Groups: 18F-flutemetamol
Cardiomyopathies Clinical Trial 2023: (18F)Flutemetamol Highlights & Side Effects. Trial Name: NCT05374564 — Phase 1
(18F)Flutemetamol (Diagnostic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05374564 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has 18F-flutemetamol been cleared by the FDA?

"18F-flutemetamol is still being tested for both safety and efficacy in clinical trials, so it received a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
Edward J Miller 2022. "Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05374564.
All > Cardiomyopathy
~1 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top