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The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040427
Recruitment Status : Terminated (Low enrollment)
First Posted : February 2, 2017
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Wael Jaber, The Cleveland Clinic

Study Description
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Brief Summary:
The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.

Condition or disease Intervention/treatment Phase
Cardiac Amyloidosis Drug: F-18 florbetapir Phase 4

Detailed Description:
F-18 florbetapir is currently used for the early detection of brain amyloid (Alzheimer's disease). The hypothesis is that F-18 florbetapir will detect amyloid deposition in myocardium prior to current non-invasive diagnostic measures, particular electrocardiography with strain and technetium pyrophosphate scintigraphy. The investigators intend to use F-18 florbetapir and assess its correlation between standard non-invasive diagnostic modalities.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 21, 2019
Actual Study Completion Date : August 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: AL or TTR type amyloidosis
The participants will undergo F-18 florbetapir PET scan.
 Drug: F-18 florbetapir
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
Other Names:
  • Amyvid
  • Florbetapir-fluorine-18
  • 18F-AV-45


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of positive studies as determined by the tracer uptake by the heart. [ Time Frame: 1 month ]
    Number of participants with extracardiac transthyretin (TTR) or Light Chain (AL) amyloid deposits with positive Florbetapir-18 PET scan


Secondary Outcome Measures :
  1. Development of clinical symptoms of cardiac amyloidosis by conventional cardiac testing. [ Time Frame: 1 year ]
    To determine that if florbetapir F18 scan can be used to detect the early amyloid involvement of the heart

  2. Correlation of F-18 florbetapir PET scan with TcPYP scan. [ Time Frame: 1 month ]
    Correlation of TcPYP nuclear scintigraphy with F-18 florbetapir PET scan in patients with ATTR


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
  2. Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50

Exclusion Criteria:

  1. Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
  2. Contraindication to florbetapir or its components
  3. Refusal to participate in the study
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): NCT03040427


Locations
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United States, Ohio
Cleveland Clinic Foundation (Main Campus)
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Wael Jaber
Avid Radiopharmaceuticals
Investigators
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Study Chair: Steven Nissen, MD The Cleveland Clinic
Principal Investigator: Wael Jaber, MD The Cleveland Clinic
More Information
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Responsible Party: Wael Jaber, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03040427    
Other Study ID Numbers: 16-960
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Wael Jaber, The Cleveland Clinic:
F-18 florbetapir
Amyvid
PET scan
Early detection
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases