Clinical Trial: PET/MRI Evaluation of Cardiac Amyloid

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 18F‑Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid

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.

Detailed Summary:

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.


Sponsor: Stanford University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: April 13, 2017
Date Started: May 26, 2016
Date Completion: August 2020
Last Updated: April 13, 2017
Last Verified: April 2017