PET/MRI Evaluation of Cardiac Amyloid

Study Overview
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Brief Summary
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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
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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: Diagnosis of cardiac amyloidosis 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.

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

Conditions
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Cardiac Amyloidosis

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-Florbetaben (Neuraceq®) PET/MRI<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with 18F-Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images | 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 | an estimated average of 2 hours |