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PET/MRI Evaluation of Cardiac Amyloid

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ClinicalTrials.gov Identifier: NCT03119558
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

Brief Summary:
Cardiac amyloidosis is a disorder characterized by the deposition of abnormal proteins called amyloid in the heart tissue. This makes it difficult for the heart to function properly. The investigators wish to evaluate if the radiopharmaceutical 18F‑Florbetaben (Neuraceq®) that targets beta amyloid can also identify cardiac amyloid deposition.

Condition or disease Intervention/treatment Phase
Cardiac Amyloidosis Drug: 18F‑Florbetaben (Neuraceq®) PET/MRI Early Phase 1

Detailed Description:

The use of hybrid positron emission tomography/ magnetic resonance imaging (PET/MRI) scanners in clinical practice enhance the ability to evaluate the heart from both an anatomical and functional perspective. It is hypothesized that an increased PET signal of 18F‑Florbetaben (Neuraceq®) will be detected in cardiac amyloid deposits within the heart tissue, while the MRI provides the anatomical information. The ability to reliably and non-invasively image amyloid deposition in the heart would be potentially advantageous in the following scenarios:

  1. Diagnosis of cardiac amyloidosis
  2. Decreasing unnecessary invasive myocardial procedures.

The investigators believe this trial will help expand the use of current PET amyloid tracers and help many patients who currently undergo myocardial biopsy for the diagnosis of cardiac amyloid.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F‑Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
Actual Study Start Date : May 26, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arm Intervention/treatment
Experimental: 18F‑Florbetaben (Neuraceq®) PET/MRI
Participants with known or suspected cardiac amyloidosis will be injected with 8 mCi of 18F‑Florbetaben (Neuraceq®) and undergo the PET/MRI image acquisition 45‑60 minute post-injection. PET and MRI data will be acquired simultaneously to ensure optimal timing and spatial correspondence between MRI and PET data. Total scan time will take approximately 60 minutes.
Drug: 18F‑Florbetaben (Neuraceq®) PET/MRI
Administration of 8.0 mCi 18F‑Florbetaben (Neuraceq®) IV followed by simultaneous acquisition PET emission and cardiac MRI sequence scan 45-60 minutes post-injection.




Primary Outcome Measures :
  1. Number of participants with 18F‑Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images [ Time Frame: an estimated average of 2 hours ]
    Diffuse (widespread), focal (point) and focal-on-diffuse (combination of the two) patterns of 18F-Florbetaben uptake will be considered positive findings indicating cardiac amyloidosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years old at the time of the scan
  • Patient with known or suspected cardiac amyloidosis.
  • Patient is capable of complying with study procedures

Exclusion Criteria:

  • Patient is pregnant or nursing
  • Metallic implants (contraindicated for MRI)
  • History of renal insufficiency (only for MRI contrast administration)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119558


Contacts
Contact: Andrea Otte (650) 736-4183 anotte@stanford.edu
Contact: Lacey Greene, BS 6507254712 lacey.greene@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andrea Otte    650-736-4183    anotte@stanford.edu   
Contact: Lacey Greene, BS    6507254712    lacey.greene@stanford.edu   
Sub-Investigator: Robert Herfkens, MD         
Principal Investigator: Andrei Iagaru, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrei Iagaru, MD Stanford University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrei Iagaru, Associate Professor of Radiology - Nuclear Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03119558     History of Changes
Other Study ID Numbers: IRB-35049
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases