3D Printed Custom Applicators for HDR BT (DISCO)

Royal North Shore Hospital

Status: Enrolling

Conditions: Endometrial Cancer; Vaginal Cancer; Gynecologic Cancer; Vulva Cancer

Treatments: Device: 3D-printed custom applicator

Study type: Interventional

Funder types: Other

Identifiers

NCT06432478

DISCO

Details and patient eligibility

About

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.

Full description

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. Current workflows for designing and constructing custom applicators with wax moulds are complex, time consuming and can result in a device that fails to meet original design specifications dictated by the planning system. In contrast, 3D-printed custom applicators provide the ability to design and print patient-specific devices that match optimal design specifications. The workflow for 3D-printed applicators is also more efficient with lower turn-around time and labour/equipment costs, and ensures a more robust product for treatment. Despite these advantages there is currently no radiotherapy department offering 3D printed custom applicators at present. This study will investigate the feasibility of successfully treating gynaecological cancers with 3D-printed custom applicators.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Gynaecological HDR brachytherapy patients

Experimental group

Description:

Using 3D-printed custom applicators to treat gynaecological HDR brachytherapy patients

Treatment:

Device: 3D-printed custom applicator