DaRT-Basket
Research type
Research Study
Full title
A Basket Study of Intra-tumoural Diffusing Alpha-emitters Radiation Therapy (DaRT) for the Treatment of Malignant Tumours
IRAS ID
357805
Contact name
Li Tee Tan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The effectiveness of current local treatments for solid cancers (surgery and radiotherapy) is limited by the need to minimise damage to surrounding organs.
Alpha Tau Medical Ltd. has developed a novel treatment known as Diffusing Alpha-emitters Radiation Therapy (DaRT) which combines the destructive power of alpha radiation with the physical advantages of interstitial brachytherapy (a form of radiotherapy where radiation sources are inserted directly into tumours). Alpha radiation has very limited penetration in tissue (a few microns) - the DaRT device overcomes this by loading Radium-224 onto thin stainless-steel wires (DaRT sources). When the sources are inserted into a tumour, short-lived alpha-emitting atoms are released which disperse by diffusion. The diffusion zone is ~5mm in tumours but <2mm in normal tissue.
In the first-in-human DaRT study of 28 patients with skin and oral cavity cancers, the response rate was 100% with no G3 adverse events even though 42% of patients had received prior radiotherapy. DaRT is now being investigated in other tumour sites (pancreas, prostate, vulva, breast, rectum, lung, liver, brain) worldwide. 247 patients have been treated to date and there have been only three G3 treatment-related adverse events. Measured radiation doses in patients and staff were negligible.
In the UK, DaRT has only been used to treat vulva cancers. Eight patients were treated – the response rate at 4 weeks was 75% and there were no G3 treatment-related adverse events. The aim of this study is to extend the use of DaRT to any patient who may benefit. Patients will be divided into 3 groups - curable, previously irradiated, incurable. Primary endpoint is response rate at 6 weeks. Secondary endpoints include response rate at 12 weeks, 3 and 6-month local control, number of G3 adverse events and patient quality-of-life. The study will recruit 85 patients in up to 5 centres.
REC name
South East Scotland REC 02
REC reference
26/SS/0028
Date of REC Opinion
21 Apr 2026
REC opinion
Further Information Favourable Opinion