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A Safety and Efficacy Study of Intra-tumoural Diffusing Alpha Radiation Emitters for the Treatment of Vulva Cancer

NCT04761146 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-05-25

No results posted yet for this study

Summary

An investigation to investigate the use of diffusing alpha-emitters radiation therapy (DaRT) for the treatment of new and recurrent squamous cell carcinoma of the vulva.

Conditions

  • Vulva Cancer, Recurrent
  • Vulvar Squamous Cell Carcinoma
  • Vulva Cancer

Interventions

RADIATION

DaRT Diffusing Alpha-emitters Radiation Therapy

DaRT is a brachytherapy treatment comprising stainless-steel 316LVM wires coated with radium-224 (Alpha DaRT seeds). The radioactive seeds are inserted directly into the tumour on the perineum and will be removed after 14 days.

Sponsors & Collaborators

  • Alpha Tau Medical LTD.

    collaborator INDUSTRY

  • CCTU- Cancer Theme

    lead OTHER

Principal Investigators

  • Li Tee Tan · Cambridge University Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-28
Primary Completion
2025-09-01
Completion
2026-01-01

Countries

  • United Kingdom

Study Locations

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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 NCT04761146 on ClinicalTrials.gov