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Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

CompletedPhase 1

Sponsor: Yale University

Conditions: Cardiomyopathies, Primary

Interventions: (18F)Flutemetamol

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

New Haven, Connecticut, United States