Actively Recruiting
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR Imaging
Led by Stanford University · Updated on 2025-04-06
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a new brain-dedicated PET insert for an MRI scanner to capture simultaneous PET/MR images of human brains. This study aims to compare the imaging quality of this novel PET insert with a commercial whole-body integrated PET/MRI system using a common radiopharmaceutical. Up to 40 participants will be involved, including healthy adults and those previously injected with PET tracers. Participants are divided into two groups: one group of 20 will receive an FDA-approved radiotracer injection such as amyloid or FDG before undergoing PET/MR imaging with the brain PET insert inside a 3T MRI scanner. The other 20 have already been injected for other PET imaging studies and will undergo PET/MR imaging using the same PET insert without additional injections. Both groups undergo combined PET and MRI scans during the imaging session. During the study, participants will provide written consent and complete a self-reported health questionnaire. Imaging performance is monitored through PET/MR images collected over a period of up to 24 months. The study also tracks radiation exposure and excludes individuals with cancer, pregnancy, nursing, or metallic implants. Overall, participants engage in imaging visits without receiving therapeutic treatments, and safety is observed throughout the trial.
CONDITIONS
Brief Title
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Whole body radiation dose within the last year of less than 5000 mrem
- Willing and able to undergo injection of 6-12 mCi of FDA-approved radiotracer (FDG or Neuraceq) if not pre-injected
- At least 21 years of age
- Provides written informed consent
- Deemed healthy by the principal investigator via self-reported questionnaire
You will not qualify if you...
- Known allergy to imaging agents for participants receiving tracer injection
- History of or current diagnosis of cancer
- Pregnant or nursing
- Presence of metallic implants contraindicated for MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a PET scan using a novel PET insert placed within a 3T MRI scanner. Participants either receive an injection of an FDA-approved radiotracer or are pre-injected from another imaging study before undergoing PET/MR imaging.
1 imaging visit (in-person)
Duration - Up to 24 months
Participants are monitored for imaging outcomes and any related observations up to 24 months following the imaging procedure.
Follow-up visits may occur depending on study assessments
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
P
Paul Newswanger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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