Brain DiseaseNCT04383808
Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
A study testing Injected radiotracer with PET Insert and Pre-injected group with PET insert in people with Brain Disease, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Disease
- What is being tested?
- Injected radiotracer with PET Insert and Pre-injected group with PET insert
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Paul Newswanger, MPH, 650-736-1349, pdn@stanford.edu
About this study
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.
Read the 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
- Conditions
- Brain Disease
- Being tested
- Injected radiotracer with PET Insert, Pre-injected group with PET insert
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injected radiotracer with PET InsertDiagnostic test
- 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 insertDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Arm-1 | Experimental | 20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. Receives: Diagnostic Test: Injected radiotracer with PET Insert |
| Arm-2 | Experimental | 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. Receives: Diagnostic Test: Pre-injected group with PET insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
PETMR image
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Apr 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Levin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383808
- Sponsor's protocol ID
- IRB-55044
- Status last verified
- Apr 2025
- First submitted
- 7 May 2020
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Translation of a Novel Brain PET Insert for Simultaneous PET/MR
- ClinicalTrials.gov ID
- NCT04383808
- Acronym / sponsor ID
- IRB-55044
- Conditions
- Brain Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm-1 | Experimental | Diagnostic Test: Injected radiotracer with PET Insert20 participants will be recruited, inject with radiopharmaceutical, and imaged on the 3T PETMR with PET insert. |
| Arm-2 | Experimental | Diagnostic Test: Pre-injected group with PET insert20 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injected radiotracer with PET Insert1. 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 | Arm-1 |
| Pre-injected group with PET insert1. 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. | Diagnostic test | Arm-2 |
Primary outcome
PETMR image
Time frame: Up to 24 months
The key specific measurement is the resulting PET/MR image obtained from the single subject scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injected radiotracer with PET Insert and Pre-injected group with PET insert in people with Brain Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Newswanger ((650) 736-1349, pdn@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PETMR image (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.