Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
ConditionBrain Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Injected radiotracer with PET Insert
Diagnostic test1. 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.
Pre-injected group with PET insert
Diagnostic test1. 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm-1Experimental treatment 1 intervention
Group B: Arm-2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PETMR image
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov