Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
研究概览
简要总结
Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.
详细描述
Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •Patients indicated for intracavitary brachytherapy
- •FIGO stage I-IVA
- •Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer
排除标准
- •Pregnancy
- •Patients contraindicated for brachytherapy
- •Inflammatory bowel disease/history of adhesions/bowel obstruction
- •Renal transplant/horseshoe kidney
- •Patients with significant LVSI or pelvic sidewall invasion
- •Patients requiring interstitial brachytherapy implants
研究组 & 干预措施
Gynaecological HDR brachytherapy patients
Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients
干预措施: 3D-printed custom applicator (Device)
结局指标
主要结局
Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
时间窗: 5 years
To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically.
次要结局
- To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria(5 years)
- To measure resources such as procedure times and demonstrate acceptable timescales for the process(5 years)
- To assess patient experience and acceptability of the process with questionnaires(5 years)
- Determine feasibility of a pre-planned MR-only procedure(5 years)
- To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).(5 years)
- Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure(5 years)
- To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.(5 years)
- To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process(5 years)
研究者
Marita Morgia
Principal Investigator
Royal North Shore Hospital