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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT04383808
Status
Recruiting
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Conditions

  • Brain Disease

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Injected radiotracer with PET Insert — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

PETMR image [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Paul Newswanger, MPH
[email protected]
650-736-1349

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By research site
Stanford University· Palo Alto, CA

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