← 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)
Must not have
Prior liver or heart transplantation
Primary amyloidosis (AL) or secondary amyloidosis (AA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a liver or heart transplant.
Select...
I have been diagnosed with primary or secondary amyloidosis.
Select...
I am allergic to 18F-flutemetamol or polysorbate 80.
Select...
I have been treated for heart or nerve issues due to amyloidosis, or I have chosen not to take tafamidis.
Select...
I have a life expectancy of more than 1 year despite my cancer or other disease.
Select...
I cannot lie flat for an hour.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,930 Previous Clinical Trials
3,033,446 Total Patients Enrolled
36 Trials studying Heart Failure
58,181 Patients Enrolled for Heart Failure
PfizerIndustry Sponsor
4,675 Previous Clinical Trials
28,717,169 Total Patients Enrolled
22 Trials studying Heart Failure
8,068 Patients Enrolled for Heart Failure
Edward J Miller, MDPrincipal InvestigatorYale University

Media Library

(18F)Flutemetamol (Diagnostic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05374564 — Phase 1
Heart Failure Research Study Groups: 18F-flutemetamol
Heart Failure 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
~2 spots leftby Jun 2025
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