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FLASH Pilot Phase 1 Safety Study

NCT07608549 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-27

No results posted yet for this study

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

Interventions

DEVICE

IntraOp Mobetron UHDR

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.

RADIATION

Linac

Conventional radiotherapy

Sponsors & Collaborators

  • Dartmouth College

    collaborator OTHER

  • Lesley A. Jarvis

    lead OTHER

Principal Investigators

  • Lesley A Jarvis, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2029-10-31
Primary Completion
2030-12-31
Completion
2031-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608549 on ClinicalTrials.gov