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

Brain Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04383808
• Other study ID #: IRB-55044
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2021
• Source: Stanford University
• Contact: David Marcellus
• Phone: 650-723-4547
• Email: dmarcel2[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Disease
• Brain Diseases

Intervention

Diagnostic Test:
• Injected radiotracer with PET Insert
Informed consent will be obtained before beginning any study procedures. 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.
• Pre-injected group with PET insert
Informed consent will be obtained before beginning any study procedures. 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.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PETMR image	The key specific measurement is the resulting PET/MR image obtained from the single subject scan.	Up to 24 months