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

Cardiac Amyloidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03040427
• Other study ID #: 16-960
• Status: Terminated
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: August 21, 2019

Study information

• Verified date: July 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 21, 2019
• Est. primary completion date: August 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation (Main Campus)	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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