Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography

NCT01683825 | Completed Phase 4 Results

• 1 other identifier: 2012P001322
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this pilot study is to determine whether amyloid deposits in the heart can be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll 15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a control group. The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind to the myocardial amyloid deposits and help quantify cardiac amyloid burden. A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of the myocardium.

Conditions

Cardiac Amyloidosis

Keywords

Amyloidosis; Cardiac; Heart; Imaging; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Mean Left Ventricular Myocardial F-18 Florbetapir SUVmean

  Standardized uptake value (SUV) mean is defined as the mean F-18 florbetapir activity concentration \[kBq/ml\] measured within the left ventricular myocardial region of interest multiplied by the decay-corrected amount of injected F-18 florbetapir \[kBq\] normalized to patient weight \[g\]. In this study we will measure mean left ventricular global myocardial F-18 Florbetapir SUVmean on static images between 4 minutes to 30 minutes post injection of F-18 florbetapir.

  1 day

Secondary Outcomes (1)

• Percent Change in Global Left Ventricular F-18 Florbetapir SUVmean From Scan 1 to Scan 2

  Repeat scan was performed a median of 7 days after baseline study (range 1-46 days)

Study Arms (3)

F-18 florbetapir PET-Amyloid Subjects

EXPERIMENTAL

Individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).

Drug: F-18 florbetapir PET

F-18 florbetapir PET-Healthy Controls

OTHER

Individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).

Drug: F-18 florbetapir PET

F-18 florbetapir PET-Amyloid Reproducibility Subjects

EXPERIMENTAL

Some of the individuals with documented cardiac amyloidosis from arm 1 will undergo a second F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET) within 30 days to measure reproducibility

Drug: F-18 florbetapir PET

Interventions

F-18 florbetapir PET DRUG

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

Also known as: F-18 labeled Florbetapir (Trade Name: Amyvid)

F-18 florbetapir PET-Amyloid Reproducibility Subjects; F-18 florbetapir PET-Amyloid Subjects; F-18 florbetapir PET-Healthy Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance of cardiac involvement, or a positive cardiac biopsy.
• Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia with appropriate tissue staining for AL) OR
• Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR staining of amyloid in tissue biopsy)
• Able and willing to provide informed consent to participate in the study procedures

You may not qualify if:

• Pregnancy
• Serious non-cardiac medical illness which will preclude research study participation

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Dorbala S, Vangala D, Semer J, Strader C, Bruyere JR Jr, Di Carli MF, Moore SC, Falk RH. Imaging cardiac amyloidosis: a pilot study using (1)(8)F-florbetapir positron emission tomography. Eur J Nucl Med Mol Imaging. 2014 Sep;41(9):1652-62. doi: 10.1007/s00259-014-2787-6. Epub 2014 May 20.

  PMID: 24841414 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Amyloidosis; Disease

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; Proteostasis Deficiencies; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample size is small. But, cardiac amyloidosis is a rare and under diagnosed disease, it is challenging to enroll more subjects. Also, due to urgency for treatment for AL amyloidosis and changes in heart failure therapy, it was challenging to perform 2 scans without changes in therapy for reproducibility assessment. There is an ongoing competing longitudinal study and most subjects chose to participate in that study, limiting recruitment to this study.

Results Point of Contact

• Title: Sharmila Dorbala, Director Nuclear Cardiology
• Organization: Brigham and Women's Hospital

sdorbala@bwh.harvard.edu

617-732-6290

Study Officials

• Sharmila Dorbala, MBBS, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Cardiology

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: September 12, 2012
• Study Start: March 23, 2013
• Primary Completion: October 4, 2018
• Study Completion: October 10, 2018
• Last Updated: November 20, 2025
• Results First Posted: April 13, 2022

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)