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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of a powerful MRI machine, known as a 7-Tesla MRI, to detect melanoma that has spread to the brain. Standard MRIs use a less powerful magnet, but the 7-Tesla MRI may provide clearer images, potentially aiding in the earlier detection and diagnosis of brain tumors. The trial targets individuals with melanoma who have new, untreated brain tumors identified by a standard MRI. Participants must be comfortable undergoing an MRI and able to lie flat without anxiety. As an unphased trial, it offers a unique opportunity to contribute to advancements in imaging technology that could improve early detection of brain tumors.

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 prior data suggests that the 7T MRI is safe for detecting melanoma brain tumors?

Research has shown that 7T MRI scans are generally safe. The stronger magnetic field of the 7T MRI produces clearer images than regular MRIs. However, some individuals might experience side effects such as dizziness, nausea, or a sense of movement during the scan. These effects are usually mild and resolve quickly. The 7T MRI offers detailed brain images, which can more effectively detect melanoma that has spread to the brain compared to the standard 3T MRI. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 7 Tesla (7T) MRI scans to detect melanoma brain tumors because this technique offers much higher resolution images compared to the standard 3 Tesla (3T) MRI scans. This means doctors could potentially see smaller tumors and more detailed structures in the brain, leading to earlier and more accurate diagnoses. Additionally, the enhanced detail might help avoid unnecessary treatments by better distinguishing between cancerous and non-cancerous tissue. This could significantly improve patient outcomes by tailoring treatments more precisely.

What evidence suggests that 7T MRI is effective for detecting melanoma brain metastases?

Research has shown that the 7T MRI, which uses a stronger magnet, captures clearer brain images than the standard 3T MRI. This trial will involve participants undergoing a 7T MRI scan, which is particularly useful for detecting melanoma brain metastases (when melanoma spreads to the brain) at an earlier stage. Early detection is crucial as it can lead to improved treatment outcomes. Studies have found that the 7T MRI provides better image quality, making it easier to identify non-cancerous brain spots as well. This could result in a more accurate and timely diagnosis for patients whose melanoma has spread to the brain. ^{1 3 4 6 7}

Who Is on the Research Team?

Lindsay Hwang

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04941430

7T MRI Scan for the Early Detection of Melanoma Brain ... Diagnostic procedures such as 7T MRI may help find and diagnose melanoma brain metastases earlier than standard 3T MRI. Detailed Description. PRIMARY OBJECTIVE:.

2. withpower.com withpower.com/trial/phase-skin-neoplasms-6-2021-b70b1

7T MRI Scan for Detecting Melanoma Brain Tumors 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6404849/

Clinical 7 T MRI: Are we there yet? A review about magnetic ... In this review, we discuss the main clinical neurological applications and some technical challenges which remain with ultra-high field MRI.

4. trials.teamjackfoundation.org trials.teamjackfoundation.org/trials/NCT04941430

7T MRI Scan for the Early Detection of Melanoma Brain ... Diagnostic procedures such as 7T MRI may help find and diagnose melanoma brain metastases earlier than standard 3T MRI. Recruitment Criteria. Accepts Healthy ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2021-05850

7T MRI Scan for the Early Detection of Melanoma Brain ... Diagnostic procedures such as 7T MRI may help find and diagnose melanoma brain metastases earlier than standard 3T MRI. Eligibility Criteria ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9131333/

Neuroimaging at 7 Tesla: a pictorial narrative review - PMC Introduction. The clinical advantages of 7-Tesla (7T) magnetic resonance imaging (MRI) include high resolution and high contrast for increased lesion detection ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4472608/

Ultra-High-Field MR Neuroimaging - PMC - PubMed Central At ultra-high magnetic fields, such as 7T, MR imaging can noninvasively visualize the brain in unprecedented detail and through enhanced contrast mechanisms.