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

NeuroTherapia, Inc.

Status and phase: Terminated; Phase 4

Conditions: Cardiac Amyloidosis

Treatments: Drug: F-18 florbetapir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03040427

16-960

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

AL or TTR type amyloidosis

Experimental group

Description:

The participants will undergo F-18 florbetapir PET scan.

Treatment:

Drug: F-18 florbetapir