Status:
COMPLETED
Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
Lead Sponsor:
Yale University
Collaborating Sponsors:
Pfizer
Conditions:
Cardiomyopathies, Primary
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 adu...
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 cha...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05374564
Start Date
August 16 2022
End Date
November 14 2024
Last Update
August 3 2025
Active Locations (1)
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1
Yale University
New Haven, Connecticut, United States, 06520