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Ultra-Fast radiation zaps skin cancer in new pilot trial

NCT ID NCT07608549

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study will test a new type of radiation called FLASH radiotherapy for people with cutaneous lymphoma, a rare skin cancer. Ten participants will receive a single, ultra-fast dose of radiation to their skin lesions. The main goal is to see if the treatment is safe and to measure how much radiation reaches the tumor.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
electron FLASH radiotherapy (ultra-high dose rate radiation delivered via Mobetron device)
What this could lead to
If successful, this could show that FLASH radiotherapy is a safe and effective way to treat skin lymphoma lesions with fewer side effects than standard radiation.
What could go wrong
This is a very early pilot study with only 10 participants, so results may not apply to everyone. The main goal is safety, not yet proving the treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2029

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologic proof of cutaneous lymphoma. 2. The cutaneous lymphoma is not planned to be treated with definitive, higher dose radiotherapy therapy. 3. Participant is planned to receive a course of palliative radiation therapy at DHMC for a cutaneous lymphomas lesion located on an extremity (see appendix A) that can be encompassed in a field size no larger than 7.5 cm in diameter. 4. No prior history of radiotherapy to the site of planned treatment. 5. Patient agrees to discontinue topical therapy, including steroid creams or chemotherapy agents, to the index lesion 4 weeks prior to the radiation treatment. 6. Participant must be capable of providing informed consent or has an acceptable surrogate capable of providing consent on behalf of the participant. 7. Adults at least 18 years of age 8. Eastern Cooperative Oncology Group performance status of \<3. 9. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12-months and capable to become pregnant, must have a negative serum beta-HCG pregnancy test result within seven days prior to start of treatment. 10. WOCBP who are sexually active must agree at study entry to use adequate methods of contraception during treatment. Exclusion Criteria: 1. Prior radiotherapy to the site of treatment. 2. Index lesion UHDR treatment field is \<5cm from the field edge of a synchronously treated CONV lesion. 3. Patient receiving prescribed hormonal therapies. 4. Patients with known NCI CTCAE V5.0 grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection. 5. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol. 6. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent process.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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