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

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
• Soft Tissue Neoplasm

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Medical Device Usage and Evaluation

Undergo MBRT with tungsten slit collimator

RADIATION

Minibeam Radiation Therapy

Undergo MBRT with tungsten slit collimator

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-11

Primary Completion

2028-08-01

Completion

2028-08-01

FDA Device

Yes

Countries

• United States

Study Locations