Trial record 15 of 56 for:    Open Studies | "Amyloidosis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Amyloid Foundation
Information provided by (Responsible Party):
Sharmila Dorbala, MBBS, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01683825
First received: September 4, 2012
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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 10 individuals with documented cardiac amyloidosis. We will also enroll 5 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.


Condition Intervention Phase
Cardiac Amyloidosis
Drug: F-18 florbetapir PET
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Mean Myocardial Radiotracer Uptake [ Time Frame: This study will take about 1.5 hours to complete. This study entails measurement of mean myocardial radiotracer dose on the images obtained on the day of the study.No follow-up is planned. ] [ Designated as safety issue: No ]

    This is a pilot feasibility study using the newly approved radiotracer F-18 florbetapir. Mean myocardial uptake will be estimated in the subjects on the images obtained Mean liver to heart ratio will be estimated. No follow-up images are planned.

    The myocardial F-18 Florbetapir images will be processed and viewed in the standard cardiac imaging planes. Visual assessment of relative myocardial uptake of F-18 Florbetapir will be performed and scored using a 0-3 scale (0=normal, 1= mild uptake, 2= moderate uptake, 3=significant uptake). Myocardial uptake of F-18 Florbetapir will be quantified using a software on the Hermes system (image viewing station). Also, specific uptake values of the radiotracer in the myocardium will be computed.



Estimated Enrollment: 15
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: F-18 florbetapir PET
10 individuals with documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
Drug: F-18 florbetapir PET
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
Other Name: F-18 labeled Florbetapir (Trade Name: Amyvid)
Experimental: Control Arm
5 individuals without documented cardiac amyloidosis will undergo F-18 florbetapir (Trade Name: Amyvid) positron emission tomography (PET).
Drug: F-18 florbetapir PET
Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
Other Name: F-18 labeled Florbetapir (Trade Name: Amyvid)

Detailed Description:

F-18 florbetapir has been studied in multiple clinical trials to image beta-amyloid deposition in the brain of subjects with Alzheimers' disease. Florbetapir F-18 has been well tolerated in studies of more than 2000 human subjects. Biodistribution studies in humans revealed predominantly hepatobiliary excretion. The tracer clears rapidly from the blood pool in about 20 minutes. This radiotracer has been recently approved for clinical imaging of brain amyloid in subjects with suspected Alzheimers disease. The investigators propose to test this FDA approved radiotracer for an off label indication in a pilot study to evaluate its potential utility, if any, to image cardiac amyloidosis.

Amyloid related heart disease is associated with LV wall thickening due to infiltration; however, this myocardial wall thickening is not definitively distinguishable from left ventricular myocyte hypertrophy from increased afterload to the heart from hypertension or aortic stenosis. Typically myocardial or other tissue biopsy with typical echo features of amyloidosis is required for confirmation of amyloidosis. This pilot study is designed to understand whether cardiac amyloid burden can be measured using a specific radiotracer targeted against amyloid protein (F-18 Florbetapir). At this point it is unknown of F-18 Florbetapir will bind to either AL or TTR amyloid protein or to both of them or to neither of them. The investigators would like to study 5 patients with AL and 5 patients with TTR amyloidosis to understand these differences if any. The investigators also seek to understand if the signal to noise ratio of the circulating amyloid protein in the blood pool (AL amyloid disease) allows for good differentiation of myocardial amyloid uptake. 5 individuals without cardiac amyloidosis will also be enrolled as controls for this study.

The purpose of the proposed research study is to examine in detail, using quantitative PET, myocardial F-18 Florbetapir uptake in cardiac amyloidosis in order to better understand mechanisms of heart damage in this disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for amyloid subjects:

  • 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

Exclusion Criteria:

  • Serious non-cardiac medical illness or a social situation which will preclude research study participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683825

Contacts
Contact: Divya Vangala, MA 857-307-2045 dvangala@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sharmila Dorbala, MBBS, MPH    857-307-1957    sdorbala@partners.org   
Principal Investigator: Sharmila Dorbala, MBBS, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Amyloid Foundation
Investigators
Principal Investigator: Sharmila Dorbala, MBBS, MPH Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Sharmila Dorbala, MBBS, Director of Nuclear Cardiology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01683825     History of Changes
Other Study ID Numbers: 2012P001322
Study First Received: September 4, 2012
Last Updated: June 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Amyloidosis
Cardiac
Heart
Imaging
Diagnosis

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014