Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy
Summary
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.
Key Facts
Lead Sponsor
Erasmus Medical Center
Enrollment
25
Start Date
2026-05-01
Completion Date
2027-12-01
Study Type
INTERVENTIONAL
Official Title
Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy
Interventions
Conditions
Eligibility
Age Range
18 Years+
Sex
FEMALE
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.
Outcome Measures
Primary Outcomes
Clinical feasibility
To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\]
Time frame: At week 2 (ARCHITECT applicator)
Secondary Outcomes
Brachytherapy-related adverse events
Organ perforation, vaginal bleeding, and device-related infection according to the common terminology criteria for adverse events (CTCAE) version 5
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator): based on imaging (organ perforation), <1 hour after applicator removal (vaginal bleeding), <1-2 weeks after removal from the patient (device-related infection)
Brachytherapy plan quality
Dosimetric parameters (according to EMBRACE II): High-Risk Clinical Target Volume D90, High-Risk Clinical Target Volume D98, Intermediate-Risk Clinical Target Volume D98, and bladder , rectum , sigmoid , and bowel D2cm3 \[Gy\]
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)
Brachytherapy implant geometry
Optimal geometry of applicator, i.e. number of needles and spacing between needles \[mm\]
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)
User experience
Questions on a scale of 1-5 where 1 indicates "strongly disagree" and 5 "strongly agree" on following the topics: easy to insert applicator, easy to connect applicator to tandem, easy to insert the needles in terms of force, easy to reach required depth with needles, easy to fixate the needles, applicator fits well, easy to remove applicator and needles, easy to reconstruct applicator or needles, applicator did not move, needles did not move, easy to connect and disconnect to after loader.
Time frame: At week 1 (standard applicator) and 2 (ARCHITECT applicator)
Time required for the workflow
Process steps evaluated on time: designing the applicator, processing at manufacturer, processing before use, in operating room, delineating targets and organs-at-risk, reconstructing, treatment planning, checking, treating, removing applicator \[hours:minutes\]
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator)
Pain perceived by patient
Perceptions of pain will be assessed using the 11-point, Numeric Rating Scale (NRS-11), where 0 indicates "no pain" and 10 represents the "worst imaginable pain"
Time frame: At week 1 (standard applicator) and week 2 (ARCHITECT applicator): <1 hour before the patient arrives at operating room, after each MR or CT imaging, and after removal from the patient
Integrity of the patient-tailored applicator
The ARCHITECT applicator will be visually inspected to detect any signs of compromised integrity: breakage \[yes/no\], cracking \[yes/no\], deformation \[yes/no\], material loss \[yes/no\].
Time frame: At week 2 (ARCHITECT applicator): after removal from the patient
Locations
Erasmus Medical Center, Rotterdam, Netherlands