PET/MRI Evaluation of Cardiac Amyloid
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|ClinicalTrials.gov Identifier: NCT03119558|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Amyloidosis||Drug: 18F‑Florbetaben (Neuraceq®) PET/MRI||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F‑Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid|
|Actual Study Start Date :||May 26, 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
Experimental: 18F‑Florbetaben (Neuraceq®) PET/MRI
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
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.
- Number of participants with 18F‑Florbetaben (Neuraceq®) uptake on Fused PET/MRI Images [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119558
|Contact: Andrea Otte||(650) firstname.lastname@example.org|
|Contact: Lacey Greene, BSemail@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Andrea Otte 650-736-4183 firstname.lastname@example.org|
|Contact: Lacey Greene, BS 6507254712 email@example.com|
|Sub-Investigator: Robert Herfkens, MD|
|Principal Investigator: Andrei Iagaru, MD|
|Principal Investigator:||Andrei Iagaru, MD||Stanford University|