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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-08-21

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Amyloidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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AL or TTR type amyloidosis

The participants will undergo F-18 florbetapir PET scan.

Group Type EXPERIMENTAL

F-18 florbetapir

Intervention Type DRUG

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

Interventions

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F-18 florbetapir

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

Intervention Type DRUG

Other Intervention Names

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Amyvid Florbetapir-fluorine-18 18F-AV-45

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No