Clinical trial · Interventional
Individual Approach in Gynecological Cancer Brachytherapy
Development and Assessment of Individual 3D Printed Applicators in MRI Guided Gynecological Brachytherapy
- 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)
MRI guided adaptive brachytherapy (BT) represents the gold standard in the treatment of gynecological cancers. Commercially available standard MRI compatible applicators for BT of gynecological cancers don't always allow for optimal target volume coverage. Three-dimensional (3D) printed technology enables versatile possibilities of improvement of standard applicators and development of novel applicators with better coverage of the target volume. The purpose of this study is to implement and assess 3D printing technology as an instrument for designing and manufacturing applicators for individualized BT of gynecological cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized 3D-Printed Brachytherapy Applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Individualized 3D-Printed Brachytherapy Applicator
- description
- Participants with gynecological cancer and suboptimal target volume coverage using standard brachytherapy applicators receive MRI-guided brachytherapy using an individually designed 3D-printed applicator. Treatment plans generated with the standard and individualized applicators are compared within the same participant.
- interventionNames
- Device: Individualized 3D-Printed Brachytherapy Applicator
Primary outcomes (2)
- measure
- Improvement in High-Risk Clinical Target Volume Coverage
- timeFrame
- During brachytherapy treatment planning, before delivery of the planned brachytherapy dose
- description
- Dose-volume parameters for the high-risk clinical target volume (HR-CTV) will be compared between treatment plans generated with a standard brachytherapy applicator and an individualized 3D-printed applicator within the same participant. Evaluated parameters include D90, D98, D100, and V100. The absolute and relative improvement achieved with the individualized applicator will be reported.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * patients with locally advanced gynecological cancer (cervical, uterine, vaginal, vulvar cancer) eligible for treatment with brachytherapy * squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma, histologically proven * patients fit for regional or general anesthesia * signed written informed consent Exclusion Criteria: * regional or general anesthesia contraindications * contraindications for MRI
References
Publications (0)
Data not yet available