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

Phase 4TerminatedNCT03040427

The Cleveland Clinic12 enrolled

Overview

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

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiac Amyloidosis

Interventions

F-18 florbetapirDRUG

Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Foundation (Main Campus)

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Quantitative Myocardial F18-florbetapir Uptake

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

Time frame: at the time of the PET scan

Data from ClinicalTrials.gov

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