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

Primary Purpose

Cardiac Amyloidosis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
F-18 florbetapir
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis focused on measuring F-18 florbetapir, Amyvid, PET scan, Early detection

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Foundation (Main Campus)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AL or TTR type amyloidosis

Arm Description

The participants will undergo F-18 florbetapir PET scan.

Outcomes

Primary Outcome Measures

Quantitative Myocardial F18-florbetapir Uptake
Number of participants with quantitative F18-florbetapir uptake above previously defined control values

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
July 7, 2021
Sponsor
The Cleveland Clinic
Collaborators
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03040427
Brief Title
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Official Title
The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 21, 2019 (Actual)
Study Completion Date
August 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
Collaborators
Avid Radiopharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis
Keywords
F-18 florbetapir, Amyvid, PET scan, Early detection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AL or TTR type amyloidosis
Arm Type
Experimental
Arm Description
The participants will undergo F-18 florbetapir PET scan.
Intervention Type
Drug
Intervention Name(s)
F-18 florbetapir
Other Intervention Name(s)
Amyvid, Florbetapir-fluorine-18, 18F-AV-45
Intervention Description
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
Primary Outcome Measure Information:
Title
Quantitative Myocardial F18-florbetapir Uptake
Description
Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Time Frame
at the time of the PET scan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis Patients with a ratio of affected to unaffected free light chains >5 or free light chain difference of >50 Exclusion Criteria: Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm Contraindication to florbetapir or its components Refusal to participate in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Nissen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wael Jaber, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation (Main Campus)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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