Gynecologic CancerNCT06432478
3D Printed Custom Applicators for HDR BT (DISCO)
A study testing 3D-printed custom applicator in people with Gynecologic Cancer and Endometrial Cancer, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Endometrial Cancer, Vaginal Cancer
- What is being tested?
- 3D-printed custom applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Nov 2023to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal North Shore Hospital
St Leonards, New South Wales, 2067
Carol Kwong, 02 9463 1339, Carolyn.Kwong@health.nsw.gov.au
Heidi Tsang, 02 9463 1340, Heidi.Tsang@health.nsw.gov.au
About this study
Official title: 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.
Read the 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.
- Conditions
- Gynecologic Cancer, Endometrial Cancer, Vaginal Cancer, Vulva Cancer
- Being tested
- 3D-printed custom applicator
- Keywords
- 3D-printed applicator, Gynaecological Cancer, Brachytherapy
- Medical subject headings
- Endometrial Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed custom applicatorDevice
3D-printed custom applicator
| Study group | Role | What they receive |
|---|---|---|
| Gynaecological HDR brachytherapy patients | Experimental | Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients Receives: Device: 3D-printed custom applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start24 Nov 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Responsible party
- Sponsor
- Investigators
- Marita Morgia, MD, Principal investigator, Royal North Shore HospitalJeremy Booth, PhD QMP, Study director, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432478
- Sponsor's protocol ID
- DISCO
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
- ClinicalTrials.gov ID
- NCT06432478
- Acronym / sponsor ID
- DISCO
- Conditions
- Gynecologic Cancer, Endometrial Cancer, Vaginal Cancer, Vulva Cancer
- Keywords
- 3D-printed applicator, Gynaecological Cancer, Brachytherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynaecological HDR brachytherapy patients | Experimental | Device: 3D-printed custom applicatorUsing 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-printed custom applicator3D-printed custom applicator | Device | Gynaecological HDR brachytherapy patients |
Primary outcome
Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
Time frame: 5 years
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.
8 secondary outcomes
To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria
Time frame: 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.
Time frame: 5 years
Determine feasibility of a pre-planned MR-only procedure
Time frame: 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).
Time frame: 5 years
Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure
Time frame: 5 years
To measure resources such as procedure times and demonstrate acceptable timescales for the process
Time frame: 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
Time frame: 5 years
To assess patient experience and acceptability of the process with questionnaires
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marita Morgia, MD principal investigator
Royal North Shore Hospital
Jeremy Booth, PhD QMP study director
Royal North Shore Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed custom applicator in people with Gynecologic Cancer and Endometrial Cancer, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marita Morgia, MD (9463 1300, Marita.Morgia@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.