3D Printed Custom Applicators for HDR BT (DISCO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3D-printed custom applicator.
- Who it may be relevant to
- Registry conditions: Gynecologic Cancer, Endometrial Cancer, Vaginal Cancer, Vulva Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
Overview
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.
Interventions
- Device 3D-printed custom applicator
3D-printed custom applicator
Primary outcome measures
- Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators. [Time frame: 5 years]
Secondary outcome measures (8)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Royal North Shore Hospital — St Leonards
Identifiers
NCT: NCT06432478 · DISCO