Cardiac Amyloidosis
Conditions
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.
Interventions
DRUG18F-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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed