Individual Approach in Gynecological Cancer Brachytherapy

NCT03466957 | Active Not Recruiting DMC

• 1 other identifier: ERID-KESOPKR/63
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer

Keywords

image guided brachytherapy; 3D print; gynecological cancer

Outcome Measures

Primary Outcomes (2)

• Improvement in High-Risk Clinical Target Volume Coverage

  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.

  During brachytherapy treatment planning, before delivery of the planned brachytherapy dose

• Number of Participants With Grade 3 or Higher Treatment-Related Toxicity

  Treatment-related toxicity involving the bladder, rectum, bowel, and vagina will be assessed using the Common Terminology Criteria for Adverse Events, version 3.0. The number and percentage of participants with new or worsening grade 3 or higher toxicity will be reported. Vaginal stenosis will be evaluated separately in accordance with the study protocol.

  From the first brachytherapy procedure through 60 months after completion of treatment

Secondary Outcomes (2)

• Dose to Organs at Risk

  During brachytherapy treatment planning, before delivery of the planned brachytherapy dose

• Local Tumor Control

  From completion of treatment through 60 months

Study Arms (1)

Individualized 3D-Printed Brachytherapy Applicator

EXPERIMENTAL

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.

Device: Individualized 3D-Printed Brachytherapy Applicator

Interventions

Individualized 3D-Printed Brachytherapy Applicator DEVICE

An individualized MRI-compatible brachytherapy applicator is designed based on the participant's anatomy, tumor location, high-risk clinical target volume, and preliminary treatment plan. The applicator is manufactured using 3D-printing technology and may include an add-on cap for oblique needles, an individualized Vienna-type applicator, or an individualized vaginal cylinder for intracavitary and interstitial brachytherapy. The aim is to improve target volume coverage while respecting dose constraints for organs at risk.

Also known as: individual applicator

Individualized 3D-Printed Brachytherapy Applicator

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• regional or general anesthesia contraindications
• contraindications for MRI

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Helena Barbara Zobec Logar, MD

  Brachytherapy Department, Institute of Oncology Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants received individualized MRI-guided gynecological brachytherapy using a 3D-printed applicator when standard applicators did not provide adequate target volume coverage. Dose-volume parameters from standard and individualized applicator treatment plans were compared within the same participant.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 15, 2018
• Study Start: May 1, 2016
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

SL (1)