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

Not Applicable

• Conditions: Brain Disease
• Interventions: Diagnostic Test: Pre-injected group with PET insert; Diagnostic Test: Injected radiotracer with PET Insert

• Registration Number: NCT04383808
• Lead Sponsor: Stanford University

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

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-14
• Last Update Posted: 2021-11-16
• Study Start: 2022-12-01
• Primary Completion: 2023-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm-2	Pre-injected group with PET insert	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.
Arm-1	Injected radiotracer with PET Insert	20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.

Primary Outcome Measures

Name	Time	Method
PETMR image	Up to 24 months	The key specific measurement is the resulting PET/MR image obtained from the single subject scan.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States