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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Florbetaben (Neuraceq®) PET/MRI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Florbetaben (Neuraceq®) PET/MRI | Drug | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Iagaru, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30043115 | Derived | Baratto L, Park SY, Hatami N, Gulaka P, Vasanawala S, Yohannan TK, Herfkens R, Witteles R, Iagaru A. 18F-florbetaben whole-body PET/MRI for evaluation of systemic amyloid deposition. EJNMMI Res. 2018 Jul 24;8(1):66. doi: 10.1186/s13550-018-0425-1. |
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| ID | Term |
|---|---|
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
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| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
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| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |