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

NCT ID: NCT04383808

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-03-31

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

Conditions

Brain Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm-1

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

Group Type: EXPERIMENTAL

Injected radiotracer with PET Insert

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Pre-injected group with PET insert

Intervention Type: 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.

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Craig Levin

Professor, Radiology/ Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul Newswanger

Role: CONTACT

pdn@stanford.edu

(650) 736-1349

Facility Contacts

Paul Newswanger, MPH

Role: primary

pdn@stanford.edu

650-736-1349

Other Identifiers

IRB-55044

Identifier Type: -

Identifier Source: org_study_id