3D Printed Custom Applicators for HDR BT (DISCO)

Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. This study is a Phase IIa non-randomised interventional pilot trial that will investigate the feasibility of successfully treating patients with 3D-printed custom applicators.

Study Overview

• Status: Recruiting
• Conditions: Gynecologic Cancer; Endometrial Cancer; Vaginal Cancer; Vulva Cancer
• Intervention / Treatment: Device: 3D-printed custom applicator

Detailed Description

Intracavitary brachytherapy for gynaecological cancer currently use cylinder-type applicators or custom wax moulds to place a radioactive source in close proximity to the treatment area and provide highly conformal dose distributions. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marita Morgia, MD; Phone Number: 9463 1300; Email: Marita.Morgia@health.nsw.gov.au
• Study Contact Backup: Name: Jeremy Booth, PhD QMP; Phone Number: 94631300; Email: jeremy.booth@health.nsw.gov.au

Study Locations

• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, 2067
      • Recruiting
      • Royal North Shore Hospital
      • Contact: Carol Kwong; Phone Number: 02 9463 1339; Email: Carolyn.Kwong@health.nsw.gov.au
      • Contact: Heidi Tsang; Phone Number: 02 9463 1340; Email: Heidi.Tsang@health.nsw.gov.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to give informed consent
• Patients indicated for intracavitary brachytherapy
• FIGO stage I-IVA
• ECOG 0-2
• Primary endometrial cancer, primary vaginal cancer, primary vulva cancer, recurrent gynaecological cancer

Exclusion Criteria:

• Pregnancy
• Patients contraindicated for brachytherapy
• Inflammatory bowel disease/history of adhesions/bowel obstruction
• Renal transplant/horseshoe kidney
• Patients with significant LVSI or pelvic sidewall invasion
• Patients requiring interstitial brachytherapy implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gynaecological HDR brachytherapy patients; Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients	Device: 3D-printed custom applicator; 3D-printed custom applicator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.	To demonstrate the feasibility of successfully simulating, planning and treating a HDR BT gynaecological patient with a 3D-printed internal mould, such that there is a dosimetric and/or clinical benefit for the patient relative to the current standard of care (cylindrical vaginal applicator). Successful treatment indicated by achieving no adverse events or difference to standard of care, and dosimentic comparisons of the 3D printed applicator plan to the cylinder plan are equivalent or better. Feasibility also determined by achieving no logistical or design issues in using the 3D printed applicators clinically.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria	RT acute and late side effects will be assessed and quantified using CTCAE criteria via clinician assessment and PROs	5 years
To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.	The plan quality of treatment plans generated for 3D-printed moulds and cylindrical applicators will be compared using dosimetric indices including target coverage (D90, Dose Homogeneity index) and organs at risk doses (D2cc, D1cc and point max) as well as patient comfort. statistical analysis (p-value) and comparison with international guidelines will be used to assess the quality of the treatment plans.	5 years
Determine feasibility of a pre-planned MR-only procedure	Feasibility of a pre-planned MR-only procedure will be determined using any of the patients that are accrued to the study who have both a CT and MRI performed at the time of simulation. The applicator and treatment plan will be generated based on the MRI and both compared to the CT-based plan and applicator. Feasibility will be indicated by generating equivalent plan quality and applicators from both methods.	5 years
To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).	The initial and final CT plan dosimetry will be compared to determine the feasibility of an initial CT-only process. Clinically insignificant differences between the plan dosimetry metrics and all within clinical tolerances will be used to quantify the difference. statistical analysis (p-value) will be used to assess the quality of the treatment plans.	5 years
Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure	The feasibility of an optimised 3D-printed applicator design based on the cylinder fitting procedure will be assessed by comparison of the 3D-printed clinical applicators with applicators derived from CT/MR of the vault in a relaxed state with an expansion applied based on the size of the cylinder applied in the fitting procedure. Feasibility will be determined by looking for a correlation between the size of the 3D printed clinical applicators and the size of the cylinders tolerated by the patient in the fitting procedure.	5 years
To measure resources such as procedure times and demonstrate acceptable timescales for the process	Procedure times will be recorded as per ARIA carepath tasks and time taken within the 3D-printed custom applicator workflow compared to the standard of care cylinder applicator workflow with equivalent or less time taken deemed acceptable	5 years
To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process	Costs associated with the 3D-printed design process will be defined and compared with the standard of care process via economic analysis of the resourcing and unit-price estimates in each arm of the respective workflows	5 years
To assess patient experience and acceptability of the process with questionnaires	Patient experience and acceptability of the 3D-printed simulation and treatment processes will be assessed with the EORTC QLQ-C30 questionnaires and success measured by comparison with the standard of care vaginal cylinder process. Questionnaires include questions with a scale of 1-4 where a higher number indicates a worse experience and a scale of 1-7 where a lower number indicates a worse experience.	5 years

Collaborators and Investigators

• Sponsor: Royal North Shore Hospital
• Collaborators: Northern Sydney and Central Coast Area Health Service
• Investigators: Principal Investigator: Marita Morgia, MD, Royal North Shore Hospital; Study Director: Jeremy Booth, PhD QMP, Royal North Shore Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Brachytherapy; Gynaecological Cancer; 3D-printed applicator
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Vulvar Diseases; Vaginal Diseases; Endometrial Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
• Other Study ID Numbers: DISCO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No