Clinical trial · Interventional
Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy
Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy
NCT07435987CI-TRIAL-00104177ARCHITECTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This prospective, non-randomised, single centre, phase I trial assesses the clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Uterine Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARCHITECT applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study arm
- description
- In general in Erasmus Medical Centre, two applications are applied with an interval of one week for the HDR IGABT. Patients will be treated with a commercially available applicator (conform the current clinical practice) at week 1 and with the patient-tailored ARCHITECT applicator (study intervention) at week 2.
- interventionNames
- Device: ARCHITECT applicator
Primary outcomes (1)
- measure
- Clinical feasibility
- timeFrame
- At week 2 (ARCHITECT applicator)
- description
- To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\]
Secondary outcomes (7)
- measure
- Brachytherapy-related adverse events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy * Written informed consent Exclusion Criteria: * Unable to give informed consent; * Tumour extension in the lower 2/3rd of the vagina; * Requiring a Geneva tandem with ovoids' size 13 mm in the first application for brachytherapy; * Known nylon allergy.
References
Publications (1)
- BACKGROUNDStraathof R, van Vliet-Perez SM, Kolkman-Deurloo IK, Wauben LSGL, Nout RA, Heijmen BJM, Rossi L, Dankelman J, van de Berg NJ. Automated planning of curved needle channels in 3D printed patient-tailored applicators for cervical cancer brachytherapy. Phys Med Biol. 2024 Nov 25;69(23). doi: 10.1088/1361-6560/ad8b08. PMID 39447602