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

NCT04383808 | Recruiting DMC FDA Device

• 1 other identifier: IRB-55044
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• PETMR image

  The key specific measurement is the resulting PET/MR image obtained from the single subject scan.

  Up to 24 months

Study Arms (2)

Arm-1

EXPERIMENTAL

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

Diagnostic Test: Injected radiotracer with PET Insert

Arm-2

EXPERIMENTAL

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.

Diagnostic Test: Pre-injected group with PET insert

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.

Arm-1

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.

Arm-2

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Paul Newswanger

CONTACT

(650) 736-1349; pdn@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiology/ Nuclear Medicine

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)