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

Primary Purpose

Brain Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injected radiotracer with PET Insert
Pre-injected group with PET insert
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm-1

Arm-2

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 7, 2020
Last Updated
November 14, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04383808
Brief Title
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Official Title
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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. 20 participants at Stanford injected with an FDA-approved PET tracer (e.g. amyloid, FDG, etc.), and 20 participants from Stanford who have been pre-injected with a radiopharmaceutical for a study on another PET imaging system

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm-1
Arm Type
Experimental
Arm Description
20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert.
Arm Title
Arm-2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Injected radiotracer with PET Insert
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pre-injected group with PET insert
Intervention Description
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.
Primary Outcome Measure Information:
Title
PETMR image
Description
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Marcellus
Phone
650-723-4547
Email
dmarcel2@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Marcellus, BS
Phone
650-723-4547
Email
dmarcel2@stanford.edu

12. IPD Sharing Statement

Learn more about this trial

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

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