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

Plain Language Summary

Simplified for easier understanding

This study (called DISCO) is testing 3D-printed, custom-made applicators used to deliver internal radiation therapy (called high-dose rate brachytherapy) for women with gynecological cancers. The goal is to see if these personalized devices improve treatment precision. **You may be eligible if...** - You can give informed consent - You are scheduled to receive internal radiation therapy (intracavitary brachytherapy) - You have been diagnosed with primary endometrial cancer, primary vaginal cancer, primary vulvar cancer, or recurrent gynecological cancer - Your cancer is at FIGO stage I through IVA - Your general health is reasonably good (ECOG score 0–2) **You may NOT be eligible if...** - You are pregnant - There is a medical reason you cannot receive brachytherapy - You have inflammatory bowel disease, a history of bowel blockage, or abdominal adhesions - You have had a kidney transplant or have a horseshoe kidney - Your cancer has significantly invaded surrounding blood vessels or the pelvic walls - You need a more invasive type of internal radiation (interstitial implants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE3D-printed custom applicator

3D-printed custom applicator


Locations(1)

Royal North Shore Hospital

St Leonards, New South Wales, Australia

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NCT06432478


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