Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

NCT05374564 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2000031407
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathies, Primary

Keywords

Transthyretin amyloidosis

Outcome Measures

Primary Outcomes (6)

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans

  6 months

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans

  6 months

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans

  6 months

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans

  6 months

• Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol

  As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans

  6 months

• Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers

  As assessed by dynamic cardiac PET between baseline and 6 months

  6 months

Secondary Outcomes (5)

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

  6 months

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

  6 months

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

  6 months

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

  6 months

• Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response

  6 months

Study Arms (1)

18F-flutemetamol

EXPERIMENTAL

All clinical trial subjects will receive 18F-flutemetamol

Drug: (18F)Flutemetamol

Interventions

(18F)Flutemetamol DRUG

18F-Flutemetamol binds to β-amyloid plaques and the F-18 isotope produces a positron signal that is detected by a PET scanner. Multiple recent studies have shown that thioflavin-analogue tracers such as 18F-flutemetamol may be able to fulfill the unmet need of elucidating the presence of amyloid deposition in the heart. Because it binds to the beta-pleated motif of the amyloid fibril due to their similarity to the thioflavin structure, 18F-Flutemetamol could potentially be used to image cardiac amyloidosis (CA)

Also known as: Vizamyl

18F-flutemetamol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \> 18 years
• \. 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)
• \. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
• \. Stated willingness to comply with all study procedures and availability for the duration of the study
• \. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
• \. 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.

You may not qualify if:

• \. Primary amyloidosis (AL) or secondary amyloidosis (AA).
• \. Prior liver or heart transplantation.
• \. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
• \. Inability to lie flat for 60 minutes in the PET scanner
• \. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
• \. Pregnancy or lactation
• \. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
• \. High risk for non-adherence as determined by screening evaluation.

Sponsors & Collaborators

• Yale University: lead
• Pfizer: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Cardiomyopathies; Amyloidosis, Hereditary, Transthyretin-Related

Interventions

flutemetamol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Edward J Miller, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: August 16, 2022
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)