Recruiting

Brain PET

Sponsor:

Stanford University

Code:

NCT04383808

Conditions

Brain Disease

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Injected radiotracer with PET Insert

Pre-injected group with PET insert

Study Details

Brief summary:

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.

Conditions

Brain Disease

Study ID

NCT04383808

Start date

Apr 1, 2025

Status verified date

Apr, 2025

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Whole body radiation dose within the last year of less than 5000 mrem
2. 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
3. Subjects will be at least 21 years of age
4. Subject provides written informed consent
5. Subject is deemed healthy by the PI by via self-reported questionnaire

Exclusion Criteria:

1. For patients who will be receiving a tracer injection, no known allergy to the imaging agents
2. Participant has a history of or current diagnosis of cancer
3. Participant is pregnant or nursing
4. Metallic implants (contraindicated for MRI)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Arm-1

20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.

experimental: Arm-2

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.

Interventions

Injected radiotracer with PET Insert

1. Informed consent will be obtained before beginning any study procedures.
2. 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.

Pre-injected group with PET insert

1. Informed consent will be obtained before beginning any study procedures.
2. 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.

Primary outcome measure

  • PETMR image [ Time Frame: Up to 24 months ]

Central Contacts and Locations

Central contacts

Paul Newswanger

(650) 736-1349pdn@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Paul Newswanger, MPH

650-736-1349pdn@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 6, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-04-06.