PET/MRI Evaluation of Cardiac Amyloid
18F-Florbetaben (Neuraceq®) PET/MRI Evaluation of Cardiac Amyloid
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started May 2016
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2018
CompletedJuly 17, 2019
July 1, 2019
2.2 years
April 13, 2017
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
18F-Florbetaben (Neuraceq®) PET/MRI
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient is pregnant or nursing
- Metallic implants (contraindicated for MRI)
- History of renal insufficiency (only for MRI contrast administration)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 30043115DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrei Iagaru, MD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Radiology - Nuclear Medicine
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
May 26, 2016
Primary Completion
August 23, 2018
Study Completion
August 28, 2018
Last Updated
July 17, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share