7T MRI Scan for Detecting Melanoma Brain Tumors

Overseen By Lindsay Hwang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Anxiolytics

Disqualifiers: Recent neurosurgery, Claustrophobia, Poor renal function, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies using a special MRI machine with a stronger magnet to take clearer pictures of the brain in patients whose melanoma has spread there. The goal is to see if this new MRI can find cancer better than the standard MRI.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. It seems you may continue with previous systemic therapy, immunotherapy, or checkpoint inhibitors, but it's best to confirm with the study team.

What data supports the effectiveness of the treatment 7T MRI for detecting melanoma brain tumors?

Research shows that 7T MRI provides high-resolution images and enhanced contrast, which can help in better visualizing brain tumors and planning treatments. It has been used effectively for imaging other brain conditions, like glioblastoma, and offers improved detail compared to lower strength MRIs. ^{1 2 3 4 5}

Is 7T MRI safe for humans?

7T MRI is generally considered safe for humans, but it can cause side effects like dizziness, nausea, and feelings of motion. There are also safety concerns with metallic implants due to the strong magnetic field, and special care is needed to avoid heating and other risks. ^{4 5 6 7 8}

How does the 7T MRI scan treatment for detecting melanoma brain tumors differ from other treatments?

The 7T MRI scan is unique because it uses an ultra-high magnetic field strength to provide highly detailed images of the brain, which can help in detecting melanoma brain tumors with greater precision compared to standard MRI scans. This advanced imaging technique offers improved spatial resolution and contrast, allowing for better visualization of brain structures and potential abnormalities. ^{2 3 4 5 9}

Research Team

Lindsay Hwang

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for adults with melanoma that may have spread to the brain. Participants must be able to undergo MRI scans without distress, have a performance status indicating they can carry out daily activities, and agree to use contraception. It's not suitable for those with poor kidney function, recent neurosurgery or radiotherapy, uncontrolled illnesses, claustrophobia severe enough to prevent MRI scans, incompatible implants, or allergies to contrast agents used in MRIs.

Inclusion Criteria

I am able to care for myself but may not be able to do active work.

I have melanoma with new brain metastases not yet treated.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants

I had brain surgery more than 30 days ago or have recovered from it.

Patients with MRI-incompatible pacemakers or MRI-incompatible implants

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Diagnostic

Patients undergo 7T MRI scan with and without contrast over 1-2 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the diagnostic procedure

2 weeks

Treatment Details

Interventions

• Magnetic Resonance Imaging using 7 Tesla MRI

Trial Overview The study is testing whether a high-resolution 7 Tesla (7T) MRI scan can detect brain metastases from melanoma more effectively than the standard 3 Tesla (3T) MRI scan. The goal is early detection of cancer spread which could lead to better treatment outcomes.

Participant Groups

Group I: Diagnostic (7T MRI) Experimental Treatment 1 Intervention

Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Ultra-high field MRI at 7 Tesla provides high-resolution images that can improve the visualization of critical organs in glioblastoma patients before radiotherapy.

The enhanced imaging from 7 Tesla FLAIR sequences may lead to better planning by potentially modifying target volumes for treatment, which could improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution FLAIR MRI at 7 Tesla for treatment planning in glioblastoma patients. Regnery, S., Knowles, BR., Paech, D., et al.[2019]

The introduction of 7 Tesla MRI represents a significant advancement in magnetic resonance imaging, potentially leading to improved diagnostic capabilities for both brain and body imaging.

This review highlights the current status of 7T MR imaging, discussing both the promising opportunities it offers and the challenges that researchers face in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7 Tesla MR imaging: opportunities and challenges. Umutlu, L., Ladd, ME., Forsting, M., et al.[2022]

The introduction of whole-body ultrahigh field MRI systems operating at 7 to 9.4 T offers new possibilities for routine patient imaging, particularly in brain tumor diagnosis, compared to lower field strength systems like 3 T and 1.5 T.

Initial experiences at the Ohio State University Medical Center indicate that these ultrahigh field MR systems present unique technological and biological challenges, but they also enhance imaging capabilities for clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical magnetic resonance imaging of brain tumors at ultrahigh field: a state-of-the-art review. Yuh, WT., Christoforidis, GA., Koch, RM., et al.[2018]

Ultra-high magnetic field MRI at 7T provides exceptional detail and contrast for brain imaging, allowing for better visualization of anatomical and vascular structures, as well as improved detection of metabolites related to various neurological disorders.

Despite its advantages, 7T MRI faces challenges such as artifacts from conventional imaging techniques, necessitating specialized pulse sequences and hardware, along with considerations for cost and patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-High-Field MR Neuroimaging. Balchandani, P., Naidich, TP.[2018]

The 7-T MRI scanner, approved by the FDA in 2017, offers significant advantages for clinical brain imaging, including improved spatial resolution and increased signal-to-noise ratio, making it suitable for detailed evaluations of conditions like brain tumors and multiple sclerosis.

Despite its benefits, the 7-T MRI introduces new technical challenges, such as artifacts and safety concerns, which require careful protocol development and optimization for effective clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Commercial 7-T MRI Scanner for Clinical Brain Imaging: Indications, Protocols, Challenges, and Solutions-A Single-Center Experience. Özütemiz, C., White, M., Elvendahl, W., et al.[2023]

7T MRI/MRS technology offers significant improvements in image quality, but it also raises safety concerns due to higher magnetic fields that can affect electrically conductive implants and increase the risk of adverse incidents.

As the use of 7T MRI/MRS expands, especially in clinical settings, institutions must develop specific safety policies and conduct informed risk/benefit analyses to address the challenges and gaps in knowledge associated with this advanced imaging technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7T MR Safety. Fagan, AJ., Bitz, AK., Björkman-Burtscher, IM., et al.[2021]

The 7T MRI system, while advanced and approved for clinical use in the U.S., raises safety concerns due to reported bioeffects such as vertigo and nausea, particularly in MR workers and researchers.

The stronger magnetic field of 7T can cause significant displacement and heating effects on metallic implants, making it crucial to avoid scanning patients with such devices unless specific safety criteria are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety for Human MR Scanners at 7T. Okada, T., Akasaka, T., Thuy, DH., et al.[2022]

7-T MRI, while approved for clinical use, presents unique safety challenges such as increased forces on metallic implants and heightened risks of radiofrequency heating.

Patients may experience more pronounced bioeffects like vertigo, nausea, and visual disturbances at 7 T compared to lower field strengths, necessitating careful risk management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Considerations of 7-T MRI in Clinical Practice. Hoff, MN., McKinney, A., Shellock, FG., et al.[2020]

Ultrahigh-field MRI systems, particularly at 7-T, show great promise for enhancing brain imaging and spectroscopy, as well as musculoskeletal imaging, due to improved signal-to-noise ratios and resolution.

Despite the advantages, challenges such as radiofrequency inhomogeneity and safety concerns need to be addressed to fully realize the clinical potential of 7-T MRI systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

7-T MR--from research to clinical applications? Moser, E., Stahlberg, F., Ladd, ME., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

High-resolution FLAIR MRI at 7 Tesla for treatment planning in glioblastoma patients. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

7 Tesla MR imaging: opportunities and challenges. [2022]

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

Clinical magnetic resonance imaging of brain tumors at ultrahigh field: a state-of-the-art review. [2018]

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

Ultra-High-Field MR Neuroimaging. [2018]

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

Use of a Commercial 7-T MRI Scanner for Clinical Brain Imaging: Indications, Protocols, Challenges, and Solutions-A Single-Center Experience. [2023]

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

7T MR Safety. [2021]

7. Japan pubmed.ncbi.nlm.nih.gov

Safety for Human MR Scanners at 7T. [2022]

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

Safety Considerations of 7-T MRI in Clinical Practice. [2020]

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

7-T MR--from research to clinical applications? [2021]