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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04383808
Enrollment
40
Registered
2020-05-12
Start date
2025-04-01
Completion date
2028-03-31
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Disease

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.

Detailed description

This study will enroll up to 40 participants. 1. 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and 2. 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

Interventions

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.

DIAGNOSTIC_TESTPre-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.

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
PETMR imageUp to 24 monthsThe key specific measurement is the resulting PET/MR image obtained from the single subject scan.

Countries

United States

Contacts

Primary ContactPaul Newswanger
pdn@stanford.edu(650) 736-1349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026