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Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT05374564
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : October 14, 2022
Sponsor:
Information provided by (Responsible Party):
Edward J Miller, Yale University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiomyopathies, Primary Drug: (18F)Flutemetamol Phase 1

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
Actual Study Start Date : August 16, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 18F-flutemetamol
All clinical trial subjects will receive 18F-flutemetamol
 Drug: (18F)Flutemetamol
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)
Other Name: Vizamyl


Outcome Measures
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Primary Outcome Measures :
  1. Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol [ Time Frame: 6 months ]
    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

  2. Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol [ Time Frame: 6 months ]
    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

  3. Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol [ Time Frame: 6 months ]
    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

  4. Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol [ Time Frame: 6 months ]
    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

  5. Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol [ Time Frame: 6 months ]
    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. Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers [ Time Frame: 6 months ]
    As assessed by dynamic cardiac PET between baseline and 6 months


Secondary Outcome Measures :
  1. Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response [ Time Frame: 6 months ]
    As determined by ATTR clinical stage baseline and following 6 months of treatment with tafamidis.

  2. Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response [ Time Frame: 6 months ]
    As determined by NT-proBNP between baseline and following 6 months of treatment with tafamidis.

  3. Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response [ Time Frame: 6 months ]
    As determined by TnT between baseline and following 6 months of treatment with tafamidis.

  4. Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response [ Time Frame: 6 months ]
    As determined by echocardiographic wall thickness between baseline and following 6 months of treatment with tafamidis.

  5. Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response [ Time Frame: 6 months ]
    As determined by global longitudinal strain between baseline and following 6 months of treatment with tafamidis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374564


Contacts
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Contact: Maxime Oriol, BS 2037856497 maxime.oriol@yale.edu
Contact: Julie Holub Julie.holub@yale.edu

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Edward Miller         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Edward J Miller, MD Yale University
More Information
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Publications of Results:

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Responsible Party: Edward J Miller, MD, PhD, Associate Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT05374564    
Other Study ID Numbers: 2000031407
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: October 14, 2022
Last Verified: October 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edward J Miller, Yale University:
Transthyretin amyloidosis
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
 Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action