Metastatic Malignant Skin NeoplasmNCT07062003
Minibeam Radiation Therapy With Tungsten Slit Collimator for the Treatment of Recurrent or Metastatic Skin or Soft Tissue Tumors
A study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Malignant Skin Neoplasm and Metastatic Malignant Soft Tissue Neoplasm, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Skin Neoplasm, Metastatic Malignant Soft Tissue Neoplasm, Recurrent Malignant Skin Neoplasm
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Computed Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2025to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Scott C. Lester, MD
About this study
Official title: A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the maximum tolerated dose (MTD) of MBRT and describe the adverse events of treatment.
SECONDARY OBJECTIVE:
- To assess the ability to maintain a distinct differential between peak and valley doses using film dosimetry.
EXPLORATORY OBJECTIVES:
- To estimate the rate of freedom from local progression at 6 and 12 months after the start of MBRT.
II. To evaluate pre-treatment and post-treatment differential abundance of peripheral blood immune cell populations and their activation markers.
III. Explore germline and somatic mutations in homologous recombination (HR) genes and their association with freedom from local progression.
IV. Quantify the immune phenotypes and cell signaling in the tumor microenvironment pre-MBRT and post-MBRT using bulk ribonucleic acid (RNA)-sequencing (seq) data.
OUTLINE:
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.
After completion of study treatment, patients are followed up at weeks 2, 4, and 12, and months 6, 9, and 12.
- Conditions
- Metastatic Malignant Skin Neoplasm, Metastatic Malignant Soft Tissue Neoplasm, Recurrent Malignant Skin Neoplasm, Recurrent Malignant Soft Tissue Neoplasm, Skin Neoplasm, Soft Tissue Neoplasm
- Being tested
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Medical Device Usage and Evaluation, Minibeam Radiation Therapy
- Medical subject headings
- Skin Neoplasms, Sarcoma, Soft Tissue Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood samples
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Medical Device Usage and EvaluationOther
Undergo MBRT with tungsten slit collimator
Minibeam Radiation TherapyRadiation
Also called MBRT
Undergo MBRT with tungsten slit collimator
| Study group | Role | What they receive |
|---|---|---|
| Device feasibility (MBRT with tungsten slit collimator) | Experimental | 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. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Other: Medical Device Usage and Evaluation; Radiation: Minibeam Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
The maximum tolerated dose is defined as the dose level associated with a dose limiting toxicity (DLT) probability closest to the target toxicity rate (30%), which will be determined based on the time-to-event Bayesian optimal interval procedures. The incidence and proportion of patients experiencing DLTs will be summarized for each dose level and across all dose levels.
Measured: Up to 28 days
Incidence of adverse events
Safety will be assessed based on reported adverse events (AEs). The severity of AEs will be graded as mild, moderate, severe, or life-threatening according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 12 months
Secondary outcomes (2)
Ability to maintain a distinct differential between peak and valley doses using film dosimetry
Film dosimetry will be obtained for every patient treatment. Radiochromic film will be placed directly on the tumor. Will measure and record peak and valley doses as well as the resulting peak-to-valley dose ratio.
Measured: Up to 12 months
Incidence of adverse events
Safety will be assessed by CTCAE 5.0 by investigating (1) grade 3 AEs deemed possibly, probably, or definitely related to study treatment and (2) all grade 4-5 AEs regardless of attribution to the study treatment. The proportions of patients with these AEs at months 6, 9, and 12 will be evaluated.
Measured: At months 6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start11 Aug 2025
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Skin NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott C. Lester, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062003
- Sponsor's protocol ID
- GMROR2471
- Other IDs
- 24-004810, MBRT1
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Finding Study of MiniBeam RadioTherapy for Skin and Superficial Soft Tissue Tumors (MBRT1)
- ClinicalTrials.gov ID
- NCT07062003
- Acronym / sponsor ID
- GMROR2471
- Conditions
- Metastatic Malignant Skin Neoplasm, Metastatic Malignant Soft Tissue Neoplasm, Recurrent Malignant Skin Neoplasm, Recurrent Malignant Soft Tissue Neoplasm, Skin Neoplasm, Soft Tissue Neoplasm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine the maximum tolerated dose (MTD) of MBRT and describe the adverse events of treatment.
SECONDARY OBJECTIVE:
- To assess the ability to maintain a distinct differential between peak and valley doses using film dosimetry.
EXPLORATORY OBJECTIVES:
- To estimate the rate of freedom from local progression at 6 and 12 months after the start of MBRT.
II. To evaluate pre-treatment and post-treatment differential abundance of peripheral blood immune cell populations and their activation markers.
III. Explore germline and somatic mutations in homologous recombination (HR) genes and their association with freedom from local progression.
IV. Quantify the immune phenotypes and cell signaling in the tumor microenvironment pre-MBRT and post-MBRT using bulk ribonucleic acid (RNA)-sequencing (seq) data.
OUTLINE:
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.
After completion of study treatment, patients are followed up at weeks 2, 4, and 12, and months 6, 9, and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device feasibility (MBRT with tungsten slit collimator) | Experimental | Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Computed Tomography, Other: Medical Device Usage and Evaluation, Radiation: Minibeam Radiation TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biopsy ProcedureAlso: Biopsy, BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Device feasibility (MBRT with tungsten slit collimator) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Device feasibility (MBRT with tungsten slit collimator) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Device feasibility (MBRT with tungsten slit collimator) |
| Medical Device Usage and EvaluationUndergo MBRT with tungsten slit collimator | Other | Device feasibility (MBRT with tungsten slit collimator) |
| Minibeam Radiation TherapyAlso: MBRTUndergo MBRT with tungsten slit collimator | Radiation | Device feasibility (MBRT with tungsten slit collimator) |
Primary outcome
Maximum tolerated dose
Time frame: Up to 28 days
The maximum tolerated dose is defined as the dose level associated with a dose limiting toxicity (DLT) probability closest to the target toxicity rate (30%), which will be determined based on the time-to-event Bayesian optimal interval procedures. The incidence and proportion of patients experiencing DLTs will be summarized for each dose level and across all dose levels.
Incidence of adverse events
Time frame: Up to 12 months
Safety will be assessed based on reported adverse events (AEs). The severity of AEs will be graded as mild, moderate, severe, or life-threatening according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
2 secondary outcomes
Ability to maintain a distinct differential between peak and valley doses using film dosimetry
Time frame: Up to 12 months
Incidence of adverse events
Time frame: At months 6, 9, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Scott C. Lester, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Malignant Skin Neoplasm and Metastatic Malignant Soft Tissue Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.