Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy

NCT07435987 | Not Yet Recruiting

• 1 other identifier: NL-011333
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Cervical Cancer; Uterine Carcinoma

Keywords

Brachytherapy; Patient-tailored applicator; 3D-printed applicator

Outcome Measures

Primary Outcomes (1)

• Clinical feasibility

  To deliver brachytherapy using the patient-tailored, 3D printed ARCHITECT applicator \[yes/no\]

  At week 2 (ARCHITECT applicator)

Secondary Outcomes (7)

• Brachytherapy-related adverse events

  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

  At week 1 (standard applicator) and week 2 (ARCHITECT applicator)

• Brachytherapy implant geometry

  At week 1 (standard applicator) and week 2 (ARCHITECT applicator)

• User experience

  At week 1 (standard applicator) and 2 (ARCHITECT applicator)

• Time required for the workflow

  At week 1 (standard applicator) and week 2 (ARCHITECT applicator)

Study Arms (1)

Study arm

EXPERIMENTAL

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.

Device: ARCHITECT applicator

Interventions

ARCHITECT applicator DEVICE

Patient-tailored, 3D-printed applicator

Study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy
• Written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, 3015 GD, Netherlands

Location

Related Publications (1)

• Straathof 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 BACKGROUND

Central Study Contacts

H. Westerveld, MD, PhD

CONTACT

+31 10 704 1249; g.westerveld@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation oncologist

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)