RecruitingNot ApplicableNCT06432478
3D Printed Custom Applicators for HDR BT (DISCO)
Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
Sponsor
Royal North Shore Hospital
Enrollment
10 participants
Start Date
Nov 24, 2023
Study Type
INTERVENTIONAL
Conditions
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. 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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria5
- 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 Criteria6
- 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
Interventions
DEVICE3D-printed custom applicator
3D-printed custom applicator
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06432478
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