What side effects are associated with this type of intervention?

Common treatments for melanoma brain metastases include surgery, stereotactic radiosurgery (SRS), and whole-brain radiation therapy (WBRT). Surgery can lead to complications such as infection, bleeding, and neurological deficits. SRS may cause localized brain swelling, radiation necrosis, and temporary neurological symptoms. WBRT is associated with more diffuse side effects, including cognitive decline, hair loss, fatigue, and skin reactions. These side effects are important considerations when planning treatment for melanoma brain metastases.

What prior FDA approvals exist?

The FDA has approved several treatments for melanoma, including checkpoint inhibitors like nivolumab and ipilimumab, which are often used in combination for enhanced efficacy. Additionally, BRAF inhibitors such as vemurafenib and dabrafenib, often combined with MEK inhibitors like trametinib, are approved for patients with BRAF-mutated melanoma. These treatments aim to manage metastatic melanoma and improve survival rates, and their effectiveness can be monitored using advanced imaging techniques like the 7T MRI, which offers superior resolution for early detection of brain metastases.

What other types of research exist?

Promising alternatives to 7T MRI for melanoma patients include multiparametric MRI, which combines different imaging sequences to provide comprehensive information about tumor characteristics, and dynamic contrast-enhanced MRI, which can predict treatment response. Additionally, neoadjuvant and adjuvant immunotherapies, particularly those targeting BRAF mutations, offer significant therapeutic benefits and could be considered alongside advanced imaging techniques.

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7T MRI Scan for Detecting Melanoma Brain Tumors

Q: What is the mechanism of action of this treatment?

The most common treatments for melanoma include surgical resection, stereotactic radiosurgery (SRS), whole-brain radiation therapy (WBRT), immunotherapy, and targeted therapy. Surgical resection involves physically removing the tumor, which is most effective when the melanoma is detected early. SRS delivers precise, high-dose radiation to the tumor, minimizing damage to surrounding brain tissue, and is often used for limited brain metastases. WBRT is used for multiple brain metastases, providing a broader treatment area but with more side effects. Immunotherapy, such as checkpoint inhibitors, boosts the body's immune system to recognize and attack melanoma cells. Targeted therapy involves drugs that specifically target genetic mutations in melanoma cells, such as BRAF inhibitors. Early detection of brain metastases using advanced imaging like 7T MRI can significantly impact treatment decisions, potentially leading to more effective and less invasive interventions.

N/A

Recruiting

Led By Lindsay Hwang

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) >= 70

Melanoma patients with new untreated brain metastases seen on CE 3T MRI

Must not have

Patients who have had brain neurosurgery =< 30 days prior to entering the study or those who have not recovered from adverse events related to that procedure

Patients with claustrophobia or anxiety limiting ability to tolerate MRI scans. Unable to tolerate MRI scan without use of anxiolytic medication or with distress requiring termination of scan or resulting in scans of poor quality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While there are typically no side effects associated with undergoing an MRI scan itself, some individuals might experience discomfort lying still during the procedure or anxiety due to the enclosed space of the scanner. There's also a small risk of allergic reaction to gadolinium-based contrast agents used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have melanoma with new brain metastases not yet treated.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I cannot undergo MRI scans due to severe claustrophobia or anxiety.

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My kidney function is very low or I am on dialysis.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I haven't had brain-directed radiotherapy in the last 30 days or recovered from its side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Presence or absence of brain metastases on 7 tesla (T) magnetic resonance imaging (MRI) as compared to the standard of care 3T MRI

Primary tumor size

Other study objectives

Incidence of diagnosis of leptomeningeal disease on CE 7T MRI brain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (7T MRI)Experimental Treatment1 Intervention

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma include surgical resection, stereotactic radiosurgery (SRS), whole-brain radiation therapy (WBRT), immunotherapy, and targeted therapy. Surgical resection involves physically removing the tumor, which is most effective when the melanoma is detected early. SRS delivers precise, high-dose radiation to the tumor, minimizing damage to surrounding brain tissue, and is often used for limited brain metastases. WBRT is used for multiple brain metastases, providing a broader treatment area but with more side effects. Immunotherapy, such as checkpoint inhibitors, boosts the body's immune system to recognize and attack melanoma cells. Targeted therapy involves drugs that specifically target genetic mutations in melanoma cells, such as BRAF inhibitors. Early detection of brain metastases using advanced imaging like 7T MRI can significantly impact treatment decisions, potentially leading to more effective and less invasive interventions.