NCT06432478 3D Printed Custom Applicators for HDR BT (DISCO)
| NCT ID | NCT06432478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal North Shore Hospital |
| Condition | Gynecologic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-11-24 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-11-24 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Marita Morgia, MD
PRINCIPAL INVESTIGATOR
Royal North Shore Hospital
Frequently Asked Questions
Who can join the NCT06432478 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Gynecologic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06432478 currently recruiting?
Yes, NCT06432478 is actively recruiting participants. Contact the research team at Marita.Morgia@health.nsw.gov.au for enrollment information.
Where is the NCT06432478 trial being conducted?
This trial is being conducted at St Leonards, Australia.
Who is sponsoring the NCT06432478 clinical trial?
NCT06432478 is sponsored by Royal North Shore Hospital. The principal investigator is Marita Morgia, MD at Royal North Shore Hospital. The trial plans to enroll 10 participants.
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