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

Phase 4

Terminated

• Conditions: Cardiac Amyloidosis
• Interventions: Drug: F-18 florbetapir

• Registration Number: NCT03040427
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-31
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-02
• Primary Completion: 2019-08-21
• Study Completion: 2019-08-21
• Results First Submitted: 2021-05-11
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Results First Posted: 2021-07-27
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL or TTR type amyloidosis	F-18 florbetapir	The participants will undergo F-18 florbetapir PET scan.

Primary Outcome Measures

Name	Time	Method
Quantitative Myocardial F18-florbetapir Uptake	at the time of the PET scan	Number of participants with quantitative F18-florbetapir uptake above previously defined control values

Trial Locations

Locations (1)

Cleveland Clinic Foundation (Main Campus); 🇺🇸 Cleveland, Ohio, United States