Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR

Study Overview
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Brief Summary
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The primary goal of this project is to study the feasibility of a brain-dedicated PET insert for an MR scanner for simultaneous acquisition of PET/MR images of human brains. The study will also allow us to compare the imaging performance of the investigator's brain-dedicated PET insert against a commercial whole-body permanently integrated PET/MRI system using a common radiopharmaceutical.

Detailed Description
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This study will enroll up to 40 participants. 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

Official Title
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Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR

Conditions
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Brain Disease

Intervention / Treatment
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* Diagnostic Test: Injected radiotracer with PET Insert
* Diagnostic Test: Pre-injected group with PET insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Whole body radiation dose within the last year of less than 5000 mrem Subjects intended for injected tracer studies (not associated with another study) must be willing/able to undergo injection of 6-12 mCi of either FDG or Neuraceq radiotracer. Both tracers are FDA approved Subjects will be at least 21 years of age Subject provides written informed consent Subject is deemed healthy by the PI by via self-reported questionnaire Exclusion Criteria: For patients who will be receiving a tracer injection, no known allergy to the imaging agents Participant has a history of or current diagnosis of cancer Participant is pregnant or nursing Metallic implants (contraindicated for MRI)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm-1<br>20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. | Diagnostic Test: Injected radiotracer with PET Insert<br>* Informed consent will be obtained before beginning any study procedures. Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.<br>|
| Experimental: Arm-2<br>20 participants will be recruited from other imaging studies that have been already injected (pre-injected) with a radiopharmaceutical. These subjects wont receive an additional injection of radiopharmaceutical. | Diagnostic Test: Pre-injected group with PET insert<br>* Informed consent will be obtained before beginning any study procedures. Participants who have received radiotracer for another PET imaging system. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PETMR image | The key specific measurement is the resulting PET/MR image obtained from the single subject scan. | Up to 24 months |