Trials / Recruiting
RecruitingNCT06432478
3D Printed Custom Applicators for HDR BT (DISCO)
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Royal North Shore Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3D-printed custom applicator | 3D-printed custom applicator |
Timeline
- Start date
- 2023-11-24
- Primary completion
- 2028-09-01
- Completion
- 2028-09-01
- First posted
- 2024-05-29
- Last updated
- 2026-02-06
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT06432478. Inclusion in this directory is not an endorsement.