Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)

What this Trial Is About

Researchers are evaluating the use of 3D-printed custom applicators for intracavitary high-dose-rate (HDR) brachytherapy in patients with gynaecological cancers, including endometrial, vaginal, vulva, and recurrent gynaecological cancers. This Phase IIa non-randomised pilot trial aims to assess the feasibility of treating patients using these patient-specific devices, which could offer a more precise and efficient alternative to traditional cylinder-type applicators or custom wax moulds. The study is sponsored by Royal North Shore Hospital and addresses current challenges in applicator design and construction. Participants will receive treatment using 3D-printed custom applicators designed to match optimal planning specifications for HDR brachytherapy. This innovative approach may reduce the time and labor involved in applicator preparation compared to standard wax moulds, while providing a robust and tailored device for therapy. The study focuses on intracavitary brachytherapy procedures for eligible female patients with certain stages of gynaecological cancer. During the study, patients will be closely monitored for treatment success, radiation therapy toxicities, and quality of treatment plans. Researchers will also evaluate the feasibility of MR-only and CT-only planning procedures, optimize applicator design, and assess resource use and costs. Patient experience and acceptability will be measured via questionnaires over a five-year follow-up. Safety and effectiveness outcomes will be carefully tracked to understand the potential benefits and challenges of this new technology.

3D Printed Custom Applicators for HDR BT (DISCO)