FLASH Pilot Phase 1 Safety Study (NCT07608549) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
FLASH Pilot Phase 1 Safety Study
10 participantsStarted 2029-10-31
Plain-language summary
The primary purpose of this research trial is to study the safety of electron FLASH treatment for cutaneous lymphoma lesions. In addition, investigators will confirm the accuracy of dose and dose rate delivery of electron FLASH therapy using on-patient dosimetry measurements in combination with FAST camera imaging. Researchers will also determine the response rates of cutaneous lymphomas treated with a low radiation dose in a single fraction using electron UHDR treatments, followed by an assessment of radiation related skin toxicity.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologic proof of cutaneous lymphoma.
. The cutaneous lymphoma is not planned to be treated with definitive, higher dose radiotherapy therapy.
. 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.
. No prior history of radiotherapy to the site of planned treatment.
. Patient agrees to discontinue topical therapy, including steroid creams or chemotherapy agents, to the index lesion 4 weeks prior to the radiation treatment.
. Participant must be capable of providing informed consent or has an acceptable surrogate capable of providing consent on behalf of the participant.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is described as a Phase 1 safety study focused on characterizing the toxicity profile of electron FLASH radiotherapy — what does that mean in practical terms for me, and how much is still unknown about whether this approach is safe for cutaneous lymphoma?
2Since this trial isn't recruiting yet, how long might it realistically be before it opens, and are there other treatments I should consider in the meantime rather than waiting?
3FLASH radiotherapy delivers radiation at a much higher dose rate than conventional radiation — can you explain how that difference might affect my skin and nearby tissue compared to standard radiation I could receive today?
4Because this is a pilot safety study and not yet testing effectiveness as a primary goal, does that mean we wouldn't necessarily expect proof of tumor response from this trial, and how does that weigh against starting standard treatment now?
5Is your institution involved in or affiliated with this trial, and if not, would pursuing it require me to travel to a specific center that has the specialized electron FLASH technology?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and toxicity profile characterization of electron FLASH treatment
. Patients with known NCI CTCAE V5.0 grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection.
. 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.
. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent process.