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Minibeam Radiation Therapy for Skin or Soft Tissue Tumors

This clinical trial is testing a new way to deliver radiation therapy called minibeam radiation therapy (MBRT) using a tungsten slit collimator. This treatment is for adults aged 18 and older who have skin or soft tissue tumors that have come back (recurrent) or spread to other parts of the body (metastatic). The main goals are to find the safest and most effective dose of MBRT and to understand any side effects. Researchers will also look at how well the treatment prevents the tumor from growing locally. The study plans to enroll 60 participants. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 60 participants. It aims to determine the maximum tolerated dose of MBRT.
What's involved
You would undergo MBRT with a tungsten slit collimator over 2-3 treatment sessions. You would also have a biopsy, blood draws, and CT scans throughout the study.
Compensation
Not stated in the trial record.
Follow-up
You would be followed up for up to 12 months after starting MBRT to monitor for adverse events.

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NCT07062003

Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors

Recruiting
NAAges 18+InterventionalTreatment
Mayo Clinic
~60 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionComputed TomographyMedical Device Usage and EvaluationMinibeam Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over Up to 28 days
+1 more outcome measured

Conditions

Metastatic Malignant Skin Neoplasm
Metastatic Malignant Soft Tissue Neoplasm
Recurrent Malignant Skin Neoplasm
Recurrent Malignant Soft Tissue Neoplasm
Skin Neoplasm
Soft Tissue Neoplasm

Explore related trials

Skin NeoplasmSoft Tissue Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Scott C. Lester, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 18 years
Histologically confirmed malignancy
Primary, recurrent, or metastatic skin or superficial soft tissue tumor amenable to palliative orthovoltage radiotherapy
Anticipated life expectancy ≥ 30 days and anticipated capacity for follow up for ≥ 30 days
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
Willing and able to return to enrolling institution for follow-up during the active monitoring phase of the study
Willing to provide blood and tissue samples for correlative research purposes

Exclusion

Hematologic, germ cell, or any other tumor that the investigational team would deem to have a high likelihood of clinical complete response with standard palliative radiotherapy (8 Gy in 1, 30 Gy in 10, etc.)
COHORT A (INTACT SKIN) ONLY: Prior radiotherapy targeting the lesion presenting for treatment or prior adjacent radiotherapy if \> 10 Gy overlaps with a portion of the planned target
Treatment with a B-Raf proto-oncogene, serine/threonine kinase (BRAF) inhibitor, monoclonal antibodies targeting vascular endothelial growth factor (VEGF) (bevacizumab or ramucirumab) or small molecule inhibitors inhibiting VEGF within the last 2 weeks or planned treatment with BRAF inhibitor within 4 weeks after radiation
Treatment with an investigational drug therapy within 2 weeks prior to or 4 weeks (the DLT monitoring period) after MBRT
Any tumor with direct extension into the spine such that targeting the spine/spinal cord could not be avoided

What this trial measures

  • Maximum tolerated doseUp to 28 days

    The maximum tolerated dose is defined as the dose level associated with a dose limiting toxicity (DLT) probability closest to the target toxicity rate (30%), which will be determined based on the time-to-event Bayesian optimal interval procedures. The incidence and proportion of patients experiencing DLTs will be summarized for each dose level and across all dose levels.

  • Incidence of adverse eventsUp to 12 months

    Safety will be assessed based on reported adverse events (AEs). The severity of AEs will be graded as mild, moderate, severe, or life-threatening according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.