Actively Recruiting
A Dose Finding Study of Minibeam Radiation Therapy Using a Tungsten Slit Collimator for Recurrent or Metastatic Skin and Superficial Soft Tissue Tumors
Led by Mayo Clinic · Updated on 2026-06-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating minibeam radiation therapy (MBRT) using a tungsten slit collimator for treating patients with recurrent or metastatic skin or soft tissue tumors. This trial aims to find the maximum tolerated dose and assess the safety of MBRT. The study also explores how well the treatment maintains dose differences and examines immune responses and genetic factors related to tumor progression. This is an interventional study sponsored by Mayo Clinic.
CONDITIONS
Brief Title
Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors
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 span of at least 30 days and ability to follow up for at least 30 days
- Negative pregnancy test within 28 days before registration for women who can become pregnant
- Willing to provide written informed consent
- Willing to allow baseline and follow-up photographs for response and toxicity assessment
- Willing and able to return to the enrolling site for follow-up during the active monitoring phase
- Willing to provide blood and tissue samples for research purposes
You will not qualify if you...
- Hematologic, germ cell, or other tumors likely to respond completely to standard palliative radiotherapy
- Prior radiotherapy to the lesion or adjacent area overlapping more than 10 Gy (for intact skin cohort only)
- Treatment with BRAF inhibitors or VEGF-targeting antibodies within the last 2 weeks or planned BRAF inhibitor treatment within 4 weeks after radiation
- Use of investigational drug therapy within 2 weeks before or 4 weeks after MBRT
- Tumors extending directly into the spine where spinal cord targeting cannot be avoided
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 2 to 3 treatment sessions over several days
Participants undergo minibeam radiation therapy (MBRT) with a tungsten slit collimator over 2 to 3 treatment sessions. They also undergo standard CT simulation and provide blood samples and tumor biopsies during this period.
2 to 3 visits for radiation therapy, plus additional visits for CT simulation and sample collection
Duration - Up to 12 months
After completing treatment, participants are followed to monitor safety and treatment effects with visits at weeks 2, 4, and 12, and months 6, 9, and 12.
6 follow-up visits at specified weeks and months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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