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

Stanford University

Status: Enrolling

Conditions: Brain Disease

Treatments: Diagnostic Test: Injected radiotracer with PET Insert; Diagnostic Test: Pre-injected group with PET insert

Study type: Interventional

Funder types: Other

Identifiers

NCT04383808

IRB-55044

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Arm-1

Experimental group

Description:

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

Treatment:

Diagnostic Test: Injected radiotracer with PET Insert

Arm-2

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Pre-injected group with PET insert