Minibeam Radiation Therapy for Skin Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: BRAF inhibitors, VEGF inhibitors

Disqualifiers: Hematologic tumors, Prior radiotherapy, others

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 28 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of radiation therapy called Minibeam Radiation Therapy (MBRT) for individuals with recurrent or metastatic skin or soft tissue tumors. MBRT employs a special device to focus radiation precisely, targeting cancer cells while sparing healthy tissue. The trial aims to determine the safest way to use MBRT and identify the optimal dose. It seeks patients with skin or soft tissue tumors treatable with radiation to alleviate symptoms. Participants must provide blood and tissue samples and attend follow-up visits. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in radiation therapy.

Will I have to stop taking my current medications?

The trial requires stopping certain medications. You must stop taking BRAF inhibitors, VEGF-targeting monoclonal antibodies, and small molecule inhibitors inhibiting VEGF at least 2 weeks before the trial. You also cannot have planned treatment with these or cytotoxic chemotherapy within 4 weeks after the radiation therapy.

What prior data suggests that this device is safe for treating skin or soft tissue tumors?

In a previous study, Minibeam Radiation Therapy (MBRT) was used on a patient with recurrent mucosal melanoma, a challenging type of cancer. The therapy proved to be safe and effective. Another study demonstrated that MBRT can destroy tumors while causing significantly less harm to healthy tissue compared to standard radiation treatments. This suggests that MBRT might be gentler on the body and could lead to fewer side effects.

Research also shows that MBRT, particularly when using a tungsten slit collimator, reduces skin damage while effectively controlling the tumor. This is promising as it indicates the treatment is easier on the skin and could be safer than other radiation treatments.

Overall, these findings provide encouraging evidence about the safety of MBRT for treating cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Minibeam Radiation Therapy (MBRT) for skin cancer is unique because it uses a tungsten slit collimator to deliver radiation in a more precise way. Unlike traditional radiation therapy, which can affect both cancerous and healthy tissues, MBRT aims to minimize damage to surrounding healthy skin by focusing the radiation into very narrow beams. This technique could potentially reduce side effects and improve recovery times for patients. Researchers are excited about this approach because it might offer a safer and more targeted option for treating skin cancer compared to standard radiation therapies.

What evidence suggests that minibeam radiation therapy is effective for treating skin cancer?

Research has shown that Minibeam Radiation Therapy (MBRT), which participants in this trial will receive, effectively treats tumors while causing less harm to nearby healthy tissue. Studies have found that MBRT helps control tumor growth and reduces skin damage, common issues with radiation therapy. One study reported that 56% of patients showed improvement, meaning more than half responded positively to the treatment. MBRT also boosts the immune system, potentially helping the body fight cancer cells. Overall, these findings suggest that MBRT could be a promising treatment for recurring or spreading skin tumors. ^{1 2 5 6 7}

Who Is on the Research Team?

Scott C. Lester, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for patients with recurrent or metastatic skin or soft tissue tumors. Participants must have tumors that are accessible for minibeam radiation therapy and be able to undergo procedures like CT scans, biopsies, and biospecimen collection.

Inclusion Criteria

Negative pregnancy test done ≤ 28 days prior to registration, for biological women of childbearing potential only

Willing to provide written informed consent

Willing to allow baseline and follow up photograph acquisition for response and toxicity assessment

Exclusion Criteria

I haven't taken any experimental drugs around the time of my MBRT treatment.

My cancer has spread to my spine in a way that treatment would affect my spine or spinal cord.

My cancer is likely to respond well to standard radiotherapy, according to my medical team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo MBRT with a tungsten slit collimator over 2-3 fractions, including standard of care CT simulation and collection of blood samples and biopsies

Up to 28 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at weeks 2, 4, and 12, and months 6, 9, and 12

What Are the Treatments Tested in This Trial?

Interventions

• Minibeam Radiation Therapy

Trial Overview The trial tests the safety and optimal dose of minibeam radiation therapy (MBRT) using a tungsten slit collimator on patients with specific types of tumors. MBRT aims to kill tumor cells by delivering narrow beams of high energy x-rays directly to the tumor while minimizing exposure to surrounding healthy tissues.

How Is the Trial Designed?

Group I: Device feasibility (MBRT with tungsten slit collimator) Experimental Treatment 5 Interventions

Patients undergo MBRT with a tungsten slit collimator over 2-3 fractions on study. Patients also undergo standard of care CT simulation on study and undergo collection of blood samples and punch or core biopsy throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. nature.com nature.com/articles/s41598-025-91872-6

Carbon minibeam radiation therapy results in tumor growth ... Minibeam radiation therapy (MBRT) has emerged as a promising approach, reducing normal tissue toxicity while enhancing immune responses.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2542454825000517

Minibeam Radiation Therapy for Recurrent Mucosal ... We report safe and effective use of MBRT in a highly challenging clinical scenario involving recurrent mucosal melanoma. Prior to MBRT, the patient reported in ...

3. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)04554-2/fulltext

Probing the therapeutic window of proton minibeam ... However, our results clearly show that pMBRT reduces skin toxicity while maintaining equal tumor control. We estimated a GF of less than 0.65 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11928333/

From pre-clinical studies to human treatment with proton ... This registry will gather patient and tumor characteristics, imaging, treatment data (including MBRT parameters), toxicity and survival outcomes. Discussion.

5. redjournal.org redjournal.org/article/S0360-3016(24)02948-1/fulltext

Minibeam Radiation Therapy Treatment (MBRT) Given the expected response rate of 56%, an anticipated time to symptom relief of weeks to months, and the intolerable nature of his present ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07062003

Minibeam Radiation Therapy With Tungsten Slit Collimator ... This clinical trial tests the safety and best dose of minibeam radiation therapy (MBRT) with a tungsten slit collimator for treating patients with skin or soft ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558804/

Minibeam radiation therapy enhanced tumor delivery of ... Minibeam radiation therapy has been shown to eradicate tumors and cause significantly less damage to normal tissue compared to equivalent radiation doses.