eFLASH for Skin Lesions of Malignant Melanomas

NCT06549439 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-07-28

No results posted yet for this study

Summary

This prospective single center phase I trials aims to assess feasibility and safety of electron FLASH RT for treatment of melanoma skin metastases. Feasibility will be defined as FLASH delivery with an accuracy of +/-10% for each fraction, safety will be confirmed if a maximum of 2 out of 6 patients develop dose limited toxicity.

Conditions

Interventions

RADIATION

Electron FLASH radiotherapy

A nominal electron energy of 9 MeV will be used for both Flash-RT and Conv-RT, which guarantees ≥ 90% dose coverage up to a depth of 2.8 cm. Shallower lesions will be treated with the same electron energy and with a bolus. In order to treat these patients, field sizes between 2x2cm2 and 10x10cm2 will be used, which can be delivered with sufficient flatness (\<5%) and symmetry (\<2%) by the FlashTrueBeam v2.7.5.

Sponsors & Collaborators

  • Varian, a Siemens Healthineers Company

    collaborator INDUSTRY
  • University of Zurich

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2025-05-27
Completion
2026-07-31

Countries

  • Switzerland

Study Locations

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Entities

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 NCT06549439 on ClinicalTrials.gov