Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors, MBRT1 Trial

Launched by MAYO CLINIC · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of radiation treatment called minibeam radiation therapy (MBRT) using a special device made of tungsten, a very dense metal. This treatment aims to help people with skin or soft tissue tumors that have come back after earlier treatment or have spread to other parts of the body. The tungsten device helps shape the radiation into very narrow beams, which may reduce damage to healthy tissue while targeting the tumor more precisely.

Adults aged 18 and older with confirmed skin or soft tissue tumors that can be treated with radiation might be eligible to join. Participants should be expected to live at least 30 days and be able to come back for follow-up visits. The trial is not yet recruiting, but if you join, you can expect careful monitoring, including photos and samples of blood or tissue to help understand how well the treatment works and how safe it is. Some people won’t be able to join, such as those who recently had certain cancer drugs or previous radiation to the same area. This trial focuses on finding the safest and most effective dose of this new radiation approach for tumors that are difficult to treat with standard methods.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.)
• • 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
• • Planned treatment with cytotoxic chemotherapy within the 4 weeks after MBRT (the dose limiting toxicity \[DLT\] period)
• • 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