Actively Recruiting
Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors, MBRT1 Trial
Led by Mayo Clinic · Updated on 2025-12-09
60
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 tissue tumors that have come back after a period of improvement (recurrent) or that spread from where they first started (primary site) to other places in the body (metastatic). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Tungsten is an extremely dense metal and is commonly used for blocking x-rays for minimum radiation exposure. A tungsten slit collimator is a device that separates an initially wide beam of x-rays into several very narrow individual beams of radiation. As radiation passes through the collimator, the radiation hits regions of solid tungsten and is blocked. In the open slit regions, radiation passes through to the intended target/tumor area defined by the physician. The tungsten slit collimator then selectively blocks portions of the radiation to create an alternating pattern of higher "peak" and lower "valley" radiation dose regions. These narrow beams of radiation are referred to as "minibeams" and the general approach referred to as MBRT.
CONDITIONS
Official Title
Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors, MBRT1 Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed malignancy
- Primary, recurrent, or metastatic skin or superficial soft tissue tumor suitable for palliative orthovoltage radiotherapy
- Expected life expectancy of at least 30 days and ability to follow up for 30 days or more
- Negative pregnancy test within 28 days before registration for biological women who can become pregnant
- Willingness to provide written informed consent
- Willingness to allow baseline and follow-up photos for response and toxicity assessment
- Ability and willingness to return to the study center for follow-up during the active monitoring phase
- Willingness to provide blood and tissue samples for research purposes
You will not qualify if you...
- Hematologic, germ cell, or other tumors expected to respond completely to standard palliative radiotherapy
- For Cohort A (intact skin) only: prior radiotherapy to the lesion or nearby area with more than 10 Gy overlap with planned target
- Treatment with BRAF inhibitor, monoclonal antibodies targeting VEGF, or VEGF small molecule inhibitors within 2 weeks before or planned BRAF inhibitor treatment within 4 weeks after radiation
- Treatment with investigational drug therapy within 2 weeks before or 4 weeks after MBRT
- Tumors directly invading the spine where spinal cord cannot be avoided during radiation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here