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

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Amyloidosis
• Intervention / Treatment: Drug: F-18 florbetapir

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation (Main Campus)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; 18F-AV-45; Florbetapir-fluorine-18

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Myocardial F18-florbetapir Uptake	Number of participants with quantitative F18-florbetapir uptake above previously defined control values	at the time of the PET scan

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Avid Radiopharmaceuticals
• Investigators: Study Chair: Steven Nissen, MD, The Cleveland Clinic; Principal Investigator: Wael Jaber, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): August 21, 2019
• Study Completion (Actual): August 21, 2019

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: PET scan; Early detection; F-18 florbetapir; Amyvid
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis
• Other Study ID Numbers: 16-960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No