Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Squamous cell carcinoma of the vulva is a rare cancer accounting for less than 1% of female cancers. The disease predominantly affects women over the age of 65 although the incidence in younger women is rising, a finding that has been attributed to the effect of increasing human papillomavirus (HPV) infection . The standard treatment for the primary tumour is surgical excision with the aim of achieving a 1 cm clear margin on histopathology. This requires the surgeon to remove 1.5-2 cm of surrounding normal tissue to allow for shrinkage after tissue fixation. Depending on the size and location of the tumour, the surgical procedure could vary from a wide local excision to a radical vulvectomy, including excision of adjacent structures such as the clitoris, lower urethra or anus, and/or reconstructive surgery. Wound infection and breakdown are common short-term complications of radical vulva surgery. Long term consequences include functional, cosmetic, psychological and psychosexual sequelae, which can have a significant negative impact on quality of life. Recurrence rates for vulva squamous cell carcinomas range from 15% to 33%. Local recurrence in the vulva is the most common site of relapse (70%) with the groin nodes affected in 24%, pelvic nodes in 16% and distant metastases in 19%. The treatment of choice for local recurrence is surgical excision and 5-year survival rates of up to 45% have been reported. However, patients can develop multiple recurrences over a period of time and the feasibility of surgery becomes increasingly more limited as more and more tissue is removed. Brachytherapy is a form of radiotherapy where radiation sources are placed directly in contact with or into (interstitial) cancerous tissue. The radiation emitted has a short range in tissue and the brachytherapy dose distribution conforms tightly to the location of the sources with minimal dose to the surrounding healthy tissues. Alpha Tau Medical Ltd. proposes a novel treatment for malignant tumours using intra-tumoural alpha radiation, which is delivered using the Alpha DaRT Device (Alpha DaRT applicator + Alpha DaRT seeds). The technique, known as Diffusing Alpha-emitters Radiation Therapy (DaRT), combines the advantages of conventional interstitial brachytherapy with the destructive power of alpha particles. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04761146
Study type Interventional
Source Cambridge University Hospitals NHS Foundation Trust
Contact Urology, Haematology and Medical Devices Team Clinical Trials Un
Phone 01223216083
Email cctuc@addenbrookes.nhs.uk
Status Recruiting
Phase N/A
Start date February 28, 2023
Completion date January 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT06048367 - Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT02997553 - Fluorescence for Sentinel Lymph Node Identification in Cancer Surgery Phase 3
Recruiting NCT06432478 - 3D Printed Custom Applicators for HDR BT (DISCO) N/A
Recruiting NCT06028724 - A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN)
Not yet recruiting NCT06035068 - SLN Mapping and ICG Dye for Vulvar Cancer
Recruiting NCT06161428 - Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Recruiting NCT05686226 - E7 TCR-T Cell Immunotherapy for Human Papillomavirus (HPV) Associated Cancers Phase 2
Completed NCT05529303 - Prolonged Grief and Perception of Femininity in Gynecological Cancer Patients N/A
Completed NCT04147780 - Sentinel Node Extended in Squamous Cell Vulvar Cancer
Not yet recruiting NCT05761132 - Neo-adjuvant Pembrolizumab in Vulvar Squamous Cell Carcinoma: a Clinical Proof-of-concept Study Phase 2