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Recruiting Not applicable NCT06432478

3D Printed Custom Applicators for HDR BT (DISCO)

No applicable phase (e.g. observational)
Conditions: Gynecologic Cancer Endometrial Cancer Vaginal Cancer Vulva Cancer

Sponsor: Royal North Shore Hospital

trial.available_in: БГ
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.
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.
Who can participate
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
Locations 1
Australia (1)
Royal North Shore Hospital
St Leonards , New South Wales
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
24.11.2023
Completion date
01.09.2028
Registry ID
NCT06432478
Source
anzctr
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