Simultaneous PET/MR Imaging for Brain Diseases

Overseen By Paul Newswanger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cancer, Pregnancy, Metallic implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for capturing brain images using a special PET insert with an MRI machine, potentially improving the diagnosis of brain diseases. The researchers aim to evaluate the effectiveness of this method and compare it with an existing system using a common type of imaging injection. Participants are divided into two groups: one receives a new injection for the test, while the other has already received one from another study. This trial suits healthy adults who have not experienced high radiation exposure in the past year and are willing to receive a specific imaging injection. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could enhance diagnostic techniques for brain diseases.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this imaging technique is safe for humans?

A previous study showed that the small amount of radiation from radiotracers used in PET scans is generally safe and well-tolerated by patients. The main concern arises from having multiple scans over time, not just one.

For the group receiving pre-injected radiopharmaceuticals (special drugs with a small amount of radioactivity used for imaging), research has shown this method to be safe and non-invasive. Earlier studies using similar methods reported no negative effects.

Overall, both methods in the trial are generally safe, with minimal risk. Participants should be aware that the primary concern is related to repeated exposure, not the initial scan. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of simultaneous PET/MR imaging to better understand brain diseases. Unlike traditional imaging methods, this technique combines the strengths of PET, which highlights metabolic activity, with MR, which excels at showing soft tissue detail. This dual approach could provide a more comprehensive view of brain disorders in real-time, potentially leading to earlier and more accurate diagnoses. The trial is also investigating whether using pre-injected radiopharmaceuticals can streamline the imaging process without compromising quality, which could make the technique more convenient and less invasive for patients.

What evidence suggests that this PET/MR imaging technique is effective for brain diseases?

Research shows that new PET scans can create clear images of brain inflammation, enhancing the understanding of brain conditions by highlighting disease-affected areas. Studies have found that these PET scans effectively target specific brain markers, such as Aβ plaques, which are linked to progressive brain diseases. In this trial, one group of participants will receive an injection of a radiopharmaceutical and then undergo imaging with the PET/MR system. Another group, pre-injected from other imaging studies, will undergo imaging without an additional injection. These techniques are crucial for early detection and a better understanding of brain health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy adults over 21 who haven't been exposed to high levels of radiation in the past year and are willing to undergo an injection with a small amount of radiotracer. They must not have cancer, be pregnant or nursing, or have metallic implants that would interfere with MRI.

Inclusion Criteria

Subject is deemed healthy by the PI via self-reported questionnaire

Subject provides written informed consent

I have received less than 5000 mrem of radiation in the past year.

Exclusion Criteria

Pregnant or nursing participant

Presence of metallic implants (contraindicated for MRI)

No known allergy to the imaging agents for patients receiving a tracer injection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo PET/MR imaging using the brain-dedicated PET insert and a commercial PET/MRI system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Injected radiotracer with PET Insert
• Pre-injected group with PET insert

Trial Overview

Researchers are testing a new brain-dedicated PET insert designed for MR scanners by comparing it with existing PET/MRI systems. Participants will receive injections of FDA-approved tracers like FDG or Neuraceq to capture simultaneous PET/MR images of their brains.

How Is the Trial Designed?

Group I: Arm-2 Experimental Treatment 1 Intervention

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.

Group II: Arm-1 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A study involving 249 deep brain stimulation (DBS) patients who underwent 445 MRI sessions found no adverse events related to the MRI scans, indicating that brain MRI at 1.5 Tesla is safe for DBS patients.

The study highlighted that the specific absorption rates (SAR) during scans were higher than current product labeling allows, suggesting a need for updated safety guidelines for MRI use in DBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of brain MRI after deep brain stimulation hardware implantation. Nazzaro, JM., Lyons, KE., Wetzel, LH., et al.[2010]

Integrated PET/MRI scanners provide significant advantages in imaging applications that require high soft tissue contrast and lower radiation doses, particularly benefiting cancer staging and tumor imaging.

This hybrid imaging modality shows promise in various oncological applications, as well as cardiac and brain imaging, while also being safer for young patients due to reduced radiation exposure compared to traditional PET/CT scans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of PET/MRI: current status and future perspectives. Nensa, F., Beiderwellen, K., Heusch, P., et al.[2021]

Citations

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New PET radiotracer offers clearer view of brain inflammation

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PET Scanning - StatPearls - NCBI Bookshelf - NIH

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radiologyinfo.org

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PET scans only use radiotracer injections. The radiotracer typically takes about 30-60 minutes to travel through your body and be absorbed by the area under ...

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Nuclear Medicine Neuro PET Assessment, Protocols ... - NCBI

As PET scans use small amounts of radioactive compounds, there is a minimal amount of radiation exposure. The concern occurs with multiple repeated scans.

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Brain uptake and safety of Flutemetamol F 18 injection in ...

This Phase 2 study assessed the performance of positron emission tomography (PET) brain images made with Flutemetamol F 18 Injection in ...

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Positron Emission Tomography (PET) - OU Health

What is a PET scan? A positron emission tomography (PET) scan is a type of nuclear medicine imaging test. It's used to look at various body tissues.