NCT03119558

PET/MRI Evaluation of Cardiac Amyloid

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Amyloidosis

Interventions

Type	Name	Description
DRUG	18F-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.

Timeline

• Start date: 2016-05-26
• Primary completion: 2018-08-23
• Completion: 2018-08-28
• First posted: 2017-04-18
• Last updated: 2019-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study