Parametric Cardiac 18F-flutemetamol PET Imaging in ATTR Cardiomyopathy
NCT ID: NCT05374564
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2022-08-16
2024-11-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-flutemetamol
All clinical trial subjects will receive 18F-flutemetamol
(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)
Interventions
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(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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Yale University
OTHER
Responsible Party
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Edward J Miller
MD, PhD, Associate Professor of Medicine
Principal Investigators
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Edward J Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale University
New Haven, Connecticut, United States
Countries
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References
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Other Identifiers
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2000031407
Identifier Type: -
Identifier Source: org_study_id
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