DaRT-V; CTP-VUL-00
Research type
Research Study
Full title
A Feasibility Study of Intra-tumoural Diffusing Alpha-emitters Radiation Therapy (DaRT) for the treatment of Primary and Recurrent Squamous Cell Carcinoma of the Vulva
IRAS ID
293394
Contact name
Li Tee Tan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2021-000663-72, EudraCT
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Squamous cell carcinoma (SCC) of the vulva is a rare cancer predominantly affecting elderly women. Standard treatment is complete surgical excision of the primary tumour ± inguinal lymph node dissection (LND) ± post-operative (chemo)-radiation. Treatment side-effects are considerable and have significant negative impact on quality of life (QOL).
Alpha Tau Medical Ltd. has developed a novel treatment known as Diffusing Alpha-emitters Radiation Therapy (DaRT) which combines the advantages of conventional interstitial brachytherapy with the destructive power of alpha particles.
Up to now, the clinical use of alpha radiation has been limited due to its short range in tissue (a few microns). The
Alpha DaRT Device overcomes this limitation by loading Ra-224 onto thin stainless-steel wires (Alpha DaRT seeds).
When inserted into a tumour, the Ra-224 decays and releases short-lived alpha-emitting atoms into the tumour which disperse by diffusion up to several mm away.Preclinical studies have shown DaRT to be effective in various histological types. particularly SCC, while damage to adjacent normal tissue is minimal. A clinical study in patients with skin and oral cavity cancers achieved 79% complete responses and 21% partial responses with no serious adverse events. Radiation levels in patients and staff were negligible.
This is a single-centre study to evaluate the safety and efficacy of DaRT in 10 patients with new/recurrent vulva SCC.
Participants will receive DaRT as initial treatment. DaRT seeds will be inserted into the tumour and will be removed after 14 days. Response to treatment will be evaluated at 28 days after which surgical resection of residual disease and/or LND will be performed if appropriate.Primary outcome measure is treatment-related adverse events in the post-operative and follow-up period. Secondary outcome measures are tumour response at 28 days, 3/6-month local control, patient pain score, patient QOL, and necrosis in residual tumour if removed surgically.
REC name
West of Scotland REC 4
REC reference
21/WS/0096
Date of REC Opinion
13 Sep 2021
REC opinion
Further Information Favourable Opinion