Clinical trial NCT05374564: Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
Official title: Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cardiomyopathies, Primary
Keywords: Transthyretin amyloidosis
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The proposed study will be a single-arm open-label longitudinal study of 18F-flutemetamol cardiac imaging before/after six months of tafamidis treatment in 12 patients with treatment naïve ATTR cardiac amyloidosis.
Primary purpose: TREATMENT

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 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.

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).

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.

Primary outcomes:
measure: Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
timeFrame: 6 months
measure: Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
timeFrame: 6 months
measure: Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
timeFrame: 6 months
measure: Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
timeFrame: 6 months
measure: Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
timeFrame: 6 months
measure: Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
timeFrame: 6 months
Secondary outcomes:
measure: Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
timeFrame: 6 months
measure: Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
timeFrame: 6 months
measure: Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
timeFrame: 6 months
measure: Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
timeFrame: 6 months
measure: Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Edward J Miller, MD
role: PRINCIPAL_INVESTIGATOR
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