PET/MRI Evaluation of Cardiac Amyloid

Stanford University

Status and phase: Completed; Early Phase 1

Conditions: Cardiac Amyloidosis

Treatments: Drug: 18F-Florbetaben (Neuraceq®) PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03119558

IRB-35049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

18F-Florbetaben (Neuraceq®) PET/MRI

Experimental group

Description:

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.

Treatment:

Drug: 18F-Florbetaben (Neuraceq®) PET/MRI