PET/MRI Evaluation of Cardiac Amyloid

Early Phase 1

Completed

• Conditions: Cardiac Amyloidosis
• Interventions: Drug: 18F-Florbetaben (Neuraceq®) PET/MRI

• Registration Number: NCT03119558
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05-26
• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Primary Completion: 2018-08-23
• Study Completion: 2018-08-28
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-Florbetaben (Neuraceq®) PET/MRI	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images	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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States