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

RecruitingNAAges 18 Years - anyAllMayo Clinic
NCT07062003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 defin

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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 (this does not apply to the optional Riskguard or OncoExtra samples) 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
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What it tests

  • Biopsy Procedure
  • Biospecimen Collection
  • Computed Tomography
  • Medical Device Usage and Evaluation
  • Minibeam Radiation Therapy
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Where

1 site
Mayo Clinic in Rochester
Rochester, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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