RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)

Quick Facts

Study Start:2025-08-11
Study Completion:2028-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07062003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Histologically confirmed malignancy
  3. * Primary, recurrent, or metastatic skin or superficial soft tissue tumor amenable to palliative orthovoltage radiotherapy
  4. * Anticipated life expectancy ≥ 30 days and anticipated capacity for follow up for ≥ 30 days
  5. * Negative pregnancy test done ≤ 28 days prior to registration, for biological women of childbearing potential only
  6. * Willing to provide written informed consent
  7. * Willing to allow baseline and follow up photograph acquisition for response and toxicity assessment
  8. * Willing and able to return to enrolling institution for follow-up during the active monitoring phase of the study
  9. * Willing to provide blood and tissue samples for correlative research purposes
  1. * 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.)
  2. * Prior radiotherapy targeting the lesion presenting for treatment or prior adjacent radiotherapy if \> 10 Gy overlaps with a portion of the planned target
  3. * 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
  4. * Planned treatment with cytotoxic chemotherapy within the 4 weeks after MBRT (the dose limiting toxicity \[DLT\] period)
  5. * Treatment with an investigational drug therapy within 2 weeks prior to or 4 weeks (the DLT monitoring period) after MBRT
  6. * Any tumor with direct extension into the spine such that targeting the spine/spinal cord could not be avoided

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Scott C. Lester, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11
Study Completion Date2028-08-01

Study Record Updates

Study Start Date2025-08-11
Study Completion Date2028-08-01

Terms related to this study

Additional Relevant MeSH Terms

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