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

NCT03040427 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 16-960
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Amyloidosis

Keywords

F-18 florbetapir; Amyvid; PET scan; Early detection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AL or TTR type amyloidosis

EXPERIMENTAL

The participants will undergo F-18 florbetapir PET scan.

Drug: F-18 florbetapir

Interventions

F-18 florbetapir DRUG

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

Also known as: Amyvid, Florbetapir-fluorine-18, 18F-AV-45

AL or TTR type amyloidosis

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with extra-cardiac biopsy-proven AL or ATTR amyloidosis
• Patients with a ratio of affected to unaffected free light chains \>5 or free light chain difference of \>50

You may not qualify if:

• Echocardiographic evidence of cardiac amyloidosis with septal and posterior wall thickness ≥ 13mm
• Contraindication to florbetapir or its components
• Refusal to participate in the study

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Avid Radiopharmaceuticals: collaborator

Study Sites (1)

Cleveland Clinic Foundation (Main Campus)

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Results Point of Contact

• Title: Dr. Wael A. Jaber
• Organization: Cleveland Clinic Foundation

jaberw@ccf.org

216.444.8305

Study Officials

• Steven Nissen, MD

  The Cleveland Clinic

  STUDY CHAIR

• Wael Jaber, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 2, 2017
• Study Start: January 1, 2017
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: July 27, 2021
• Results First Posted: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)