Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Australia
Royal North Shore Hospital
RECRUITING
St Leonards
Contact Information
Primary
Marita Morgia, MD
Marita.Morgia@health.nsw.gov.au
9463 1300
Backup
Jeremy Booth, PhD QMP
jeremy.booth@health.nsw.gov.au
94631300
Time Frame
Start Date: 2023-11-24
Estimated Completion Date: 2028-09
Participants
Target number of participants: 10
Treatments
Experimental: Gynaecological HDR brachytherapy patients
Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients
Sponsors
Leads: Royal North Shore Hospital

This content was sourced from clinicaltrials.gov