Clinical trial · Interventional
3D Printed Custom Applicators for HDR BT (DISCO)
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
| Vulva Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-printed custom applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gynaecological HDR brachytherapy patients
- description
- Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients
- interventionNames
- Device: 3D-printed custom applicator
Primary outcomes (1)
- measure
- Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
- timeFrame
- 5 years
- description
- 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.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Able to give informed consent * Patients indicated for intracavitary brachytherapy * FIGO stage I-IVA * ECOG 0-2 * Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer Exclusion Criteria: * 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
References
Publications (0)
Data not yet available