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

Trial Summary

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 data supports the effectiveness of this treatment for brain diseases?

Simultaneous PET/MRI imaging has shown promise in providing detailed information about brain diseases by combining the strengths of both imaging techniques. It offers high spatial resolution and sensitivity, which is particularly beneficial for neurologic applications such as neurooncology, epilepsy, and dementia. ^{1 2 3 4 5}

Is simultaneous PET/MR imaging safe for humans?

Research shows that using contrast agents for MR imaging, like gadodiamide, is generally safe and well-tolerated in humans, with only minor side effects like headaches reported in a small percentage of cases. ^{6 7 8 9 10}

How is simultaneous PET/MR imaging unique for brain diseases?

Simultaneous PET/MR imaging is unique because it combines two imaging techniques, PET (positron emission tomography) and MRI (magnetic resonance imaging), to provide detailed structural and functional information about the brain at the same time. This approach offers superior spatial resolution and sensitivity compared to traditional imaging methods, allowing for more precise assessment of brain diseases. ^{1 2 5 11 12}

What is the purpose of 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Study of compatibility between a 3T MR system and detector modules for a second-generation RF-penetrable TOF-PET insert for simultaneous PET/MRI. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Development of clinical simultaneous SPECT/MRI. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Neurologic Applications of PET/MR Imaging. [2018]

4. Turkey pubmed.ncbi.nlm.nih.gov

Clinical applications of PET/MRI: current status and future perspectives. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Development of PET/MRI with insertable PET for simultaneous PET and MR imaging of human brain. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of the safety of the standard dose and a higher dose of gadodiamide injection for MR imaging of the central nervous system. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Phase I clinical evaluation of citrate-coated monocrystalline very small superparamagnetic iron oxide particles as a new contrast medium for magnetic resonance imaging. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of the pharmacokinetics, biodistribution, and elimination of MS-325, a blood pool agent for magnetic resonance imaging. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Use of brain MRI after deep brain stimulation hardware implantation. [2010]

10. Germany pubmed.ncbi.nlm.nih.gov

[Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance)]. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Hybrid PET/MRI of intracranial masses: initial experiences and comparison to PET/CT. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Performance evaluation of RF coils integrated with an RF-penetrable PET insert for simultaneous PET/MRI. [2020]