Recruiting

MBRT

Sponsor:

Mayo Clinic

Code:

NCT07062003

Conditions

Metastatic Malignant Skin Neoplasm

Metastatic Malignant Soft Tissue Neoplasm

Recurrent Malignant Skin Neoplasm

Recurrent Malignant Soft Tissue Neoplasm

Skin Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Computed Tomography

Medical Device Usage and Evaluation

Minibeam Radiation Therapy

Study Details

Brief summary:

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

Metastatic Malignant Skin Neoplasm

Metastatic Malignant Soft Tissue Neoplasm

Recurrent Malignant Skin Neoplasm

Recurrent Malignant Soft Tissue Neoplasm

Skin Neoplasm

Study ID

NCT07062003

Start date

Aug 11, 2025

Status verified date

Jun, 2026

Completion date

Aug 1, 2028

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.)
  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Device feasibility (MBRT with tungsten slit collimator)

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.

Interventions

Biopsy Procedure

Undergo biopsy

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Medical Device Usage and Evaluation

Undergo MBRT with tungsten slit collimator

Minibeam Radiation Therapy

Undergo MBRT with tungsten slit collimator

Primary outcome measure

  • Maximum tolerated dose [ Time Frame: Up to 28 days ]
  • Incidence of adverse events [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Scott C. Lester, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-04.