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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03040427
• Collaborator: Avid Radiopharmaceuticals (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 31.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Amyloidosis	Drug: F-18 florbetapir	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Aug 21, 2019
• Actual Study Completion Date: Aug 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AL or TTR type amyloidosis The participants will undergo F-18 florbetapir PET scan.	Drug: F-18 florbetapir; Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).; Other Names: Amyvid Florbetapir-fluorine-18 18F-AV-45

Outcome Measures

Primary Outcome Measures

1. Quantitative Myocardial F18-florbetapir Uptake [at the time of the PET scan]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic Foundation (Main Campus)	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic
• Avid Radiopharmaceuticals

Investigators

• Study Chair: Steven Nissen, MD, The Cleveland Clinic
• Principal Investigator: Wael Jaber, MD, The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 22, 2016

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03040427
• Other Study ID Numbers: 16-960
• First Posted: Feb 2, 2017
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Cleveland Clinic: F-18 florbetapir; Amyvid; PET scan; Early detection
• Additional relevant MeSH terms: Amyloidosis

Study Results

Participant Flow

Arm/Group Title	At Risk for Symptomatic AL Cardiac Amyloidosis	At Risk for Symptomatic ATTR Cardiac Amyloidosis	Control Patients
Arm/Group Description	Patients with MGUS at risk for developing AL amyloidosis	Patients with biopsy proven extra-cardiac ATTR amyloidosis	Negative carpal tunnel biopsy
Period Title: Overall Study
STARTED	2	6	4
COMPLETED	2	6	4
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	At Risk for Symptomatic AL Cardiac Amyloidosis	At Risk for Symptomatic ATTR Cardiac Amyloidosis	Control Patients	Total
Arm/Group Description	Patients with MGUS at risk for developing AL amyloidosis	Patients with biopsy proven extra-cardiac ATTR amyloidosis	Negative carpal tunnel biopsy	Total of all reporting groups
Overall Participants	2	6	4	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.5 (3.5)	71.4 (5.2)	72 (6.9)	72 (5.5)
Sex: Female, Male (Count of Participants)
Female	1 50%	2 33.3%	2 50%	5 41.7%
Male	1 50%	4 66.7%	2 50%	7 58.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	1 16.7%	0 0%	1 8.3%
White	2 100%	5 83.3%	4 100%	11 91.7%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Quantitative Myocardial F18-florbetapir Uptake
Description	Number of participants with quantitative F18-florbetapir uptake above previously defined control values
Time Frame	at the time of the PET scan

Outcome Measure Data

Analysis Population Description

All participants had quantitative uptake of F18-Flobetapir

Arm/Group Title	At Risk for Symptomatic AL Cardiac Amyloidosis	At Risk for Symptomatic ATTR Cardiac Amyloidosis	Control Patients
Arm/Group Description	Patients with MGUS at risk for developing AL amyloidosis	Patients with biopsy proven extra-cardiac ATTR amyloidosis	Negative carpal tunnel biopsy
Measure Participants	2	6	4
Count of Participants [Participants]	2 100%	6 100%	4 100%

Adverse Events

Time Frame	24 hours
Arm/Group Title	At Risk for Symptomatic AL Cardiac Amyloidosis		At Risk for Symptomatic ATTR Cardiac Amyloidosis		Control Patients
Arm/Group Description	Patients with MGUS at risk for developing AL amyloidosis		Patients with biopsy proven extra-cardiac ATTR amyloidosis		Negative carpal tunnel biopsy
All Cause Mortality
	At Risk for Symptomatic AL Cardiac Amyloidosis		At Risk for Symptomatic ATTR Cardiac Amyloidosis		Control Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/6 (0%)		0/4 (0%)
Serious Adverse Events
	At Risk for Symptomatic AL Cardiac Amyloidosis		At Risk for Symptomatic ATTR Cardiac Amyloidosis		Control Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/6 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	At Risk for Symptomatic AL Cardiac Amyloidosis		At Risk for Symptomatic ATTR Cardiac Amyloidosis		Control Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/6 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.