Cutaneous LymphomaNCT07608549
FLASH Pilot Phase 1 Safety Study
A study testing IntraOp Mobetron UHDR and Linac in people with Cutaneous Lymphoma, run by Lesley A. Jarvis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Lymphoma
- What is being tested?
- IntraOp Mobetron UHDR and Linac
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2029to 31 Dec 2031
- 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
- 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.
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- Adults at least 18 years of age
- Eastern Cooperative Oncology Group performance status of <3.
- 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.
- WOCBP who are sexually active must agree at study entry to use adequate methods of contraception during treatment.
Who cannot join
- Prior radiotherapy to the site of treatment.
- Index lesion UHDR treatment field is <5cm from the field edge of a synchronously treated CONV lesion.
- Patient receiving prescribed hormonal therapies.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Pilot Study to Determine the Feasibility of Electron FLASH Radiotherapy for Treatment of De-novo Cutaneous Lymphoma
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.
- Conditions
- Cutaneous Lymphoma
- Being tested
- IntraOp Mobetron UHDR, Linac
- Keywords
- Conventional radiotherapy, Ultra-high dose rate (UDHR) radiotherapy, electron FLASH
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntraOp Mobetron UHDRDevice
The Mobetron UDHR System provides electrons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The FLASH enabled Mobetron System is intended to deliver electron FLASH radiotherapy to participants with cutaneous lymphoma lesions located in extremities.
LinacRadiation
Conventional radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm treated with FLASH Radiation Therapy | Experimental | In participants with more than one cutaneous lesion requiring treatment, one lesion will be treated with electron FLASH therapy. The prescription dose will be 8 Gray (Gy) in 1 fraction. Receives: Device: IntraOp Mobetron UHDR |
| Control arm treated with Conventional Radiation Therapy | Active comparator | In participants who have more than one cutaneous lesion requiring treatment, the remainder of the lesions not treated with electron FLASH therapy will be treated with conventional electron treatment at the discretion of the treating radiation oncologist. Receives: Radiation: Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and toxicity profile characterization of electron FLASH treatment
To study the safety and characterize the toxicity profile of electron FLASH treatment, a clinical evaluation of all lesions treated will be performed on all grade 3 or higher toxicities according to the Common Terminology Criteria for Adverse Effects (CTCAE) version 6.0.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start31 Oct 2029 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous LymphomaStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a prospective, single institution safety study of electron FLASH radiation treatment (RT) for participants with cutaneous lymphomas. The primary study objective is to determine the safety and characterize the toxicity profile of electron FLASH treatment to participants receiving palliative radiotherapy for cutaneous lymphomas. A maximum of 10 participants will be enrolled. Participants with more than one cutaneous lesion requiring treatment will have one lesion treated with electron FLASH therapy. The remainder of the lesions will be treated with conventional electron treatment, allowing such participants to serve as their own internal control. The duration of an individual participant's time in the study will include the simulation and treatment planning duration (\<4 weeks). Participants will be clinically assessed for 5 years after completion of the radiation treatment.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lesley A. Jarvis
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College
- Responsible party
- Sponsor-investigator, Lesley A. Jarvis, Dartmouth-Hitchcock Medical Center
- Investigators
- Lesley A Jarvis, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608549
- Sponsor's protocol ID
- 02003370
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 27 May 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Feasibility of Electron FLASH Radiotherapy for Treatment of De-novo Cutaneous Lymphoma
- ClinicalTrials.gov ID
- NCT07608549
- Acronym / sponsor ID
- 02003370
- Conditions
- Cutaneous Lymphoma
- Keywords
- Conventional radiotherapy, Ultra-high dose rate (UDHR) radiotherapy, electron FLASH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lesley A. JarvisUniversity, hospital or other
- Collaborators
- Dartmouth College
- Study start
- 31 Oct 2029 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 27 May 2026 (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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single institution safety study of electron FLASH radiation treatment (RT) for participants with cutaneous lymphomas. The primary study objective is to determine the safety and characterize the toxicity profile of electron FLASH treatment to participants receiving palliative radiotherapy for cutaneous lymphomas. A maximum of 10 participants will be enrolled. Participants with more than one cutaneous lesion requiring treatment will have one lesion treated with electron FLASH therapy. The remainder of the lesions will be treated with conventional electron treatment, allowing such participants to serve as their own internal control. The duration of an individual participant's time in the study will include the simulation and treatment planning duration (<4 weeks). Participants will be clinically assessed for 5 years after completion of the radiation treatment.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm treated with FLASH Radiation Therapy | Experimental | Device: IntraOp Mobetron UHDRIn participants with more than one cutaneous lesion requiring treatment, one lesion will be treated with electron FLASH therapy. The prescription dose will be 8 Gray (Gy) in 1 fraction. |
| Control arm treated with Conventional Radiation Therapy | Active comparator | Radiation: LinacIn participants who have more than one cutaneous lesion requiring treatment, the remainder of the lesions not treated with electron FLASH therapy will be treated with conventional electron treatment at the discretion of the treating radiation oncologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- Prior radiotherapy to the site of treatment.
- Index lesion UHDR treatment field is <5cm from the field edge of a synchronously treated CONV lesion.
- Patient receiving prescribed hormonal therapies.
- 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.
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 |
|---|---|---|
| IntraOp Mobetron UHDRThe Mobetron UDHR System provides electrons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. The FLASH enabled Mobetron System is intended to deliver electron FLASH radiotherapy to participants with cutaneous lymphoma lesions located in extremities. | Device | Experimental arm treated with FLASH Radiation Therapy |
| LinacConventional radiotherapy | Radiation | Control arm treated with Conventional Radiation Therapy |
Primary outcome
Safety and toxicity profile characterization of electron FLASH treatment
Time frame: 5 years
To study the safety and characterize the toxicity profile of electron FLASH treatment, a clinical evaluation of all lesions treated will be performed on all grade 3 or higher toxicities according to the Common Terminology Criteria for Adverse Effects (CTCAE) version 6.0.
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 27 May 2026.
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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.
Lesley A Jarvis, MD principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing IntraOp Mobetron UHDR and Linac in people with Cutaneous Lymphoma, run by Lesley A. Jarvis.
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 10 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Lesley A Jarvis, MD (603-650-6600, lesley.a.jarvis@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and toxicity profile characterization of electron FLASH treatment (time frame: 5 years). 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 27 May 2026.