3D Printed Custom Applicators for HDR BT (DISCO)

Sponsor
Royal North Shore Hospital
Study ID
NCT06432478
Status
Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 3D-printed custom applicator — DEVICE
    3D-printed custom applicator

Study Details

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.

Key Dates

First listed
May 29, 2024
Start date
Nov 24, 2023
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gynaecological HDR brachytherapy patients
    Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients

Primary Outcome Measure

Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators. [ Time Frame: 5 years ]

Central Contacts

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