NCT04383808

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2027-03-31
• Completion: 2028-03-31
• First posted: 2020-05-12
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study