FLASH Pilot Phase 1 Safety Study

NCT07608549 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 02003370
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cutaneous Lymphoma

Keywords

Conventional radiotherapy; Ultra-high dose rate (UDHR) radiotherapy; electron FLASH

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (2)

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.

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.

Radiation: Linac

Interventions

IntraOp Mobetron UHDR DEVICE

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.

Experimental arm treated with FLASH Radiation Therapy

Linac RADIATION

Conventional radiotherapy

Control arm treated with Conventional Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lesley A. Jarvis: lead
• Dartmouth College: collaborator

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Particle Accelerators

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiation Equipment and Supplies; Equipment and Supplies

Study Officials

• Lesley A Jarvis, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lesley A Jarvis, MD

CONTACT

603-650-6600; lesley.a.jarvis@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start (Estimated): October 31, 2029
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 27, 2026

Record last verified: 2026-05