Clinical trial NCT06432478: 3D Printed Custom Applicators for HDR BT (DISCO)
Official title: Study of 3D-printed Custom Applicators for Intracavitary HDR Gynaecological Brachytherapy (DISCO)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Endometrial Cancer
Vaginal Cancer
Vulva Cancer
Keywords: 3D-printed applicator
Gynaecological Cancer
Brachytherapy
Lead sponsor: Royal North Shore Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Successful treatment of gynaecological HDR brachytherapy patients with 3D printed intracavitary applicators.
timeFrame: 5 years
Secondary outcomes:
measure: To assess the patients radiation therapy acute and late toxicities using the CTCAE criteria
timeFrame: 5 years
measure: To compare quality of treatment plans generated for 3D-printed moulds and cylindrical applicators assessed by dosimetric indices, statistical analysis (p-value) and comparison with international guidelines.
timeFrame: 5 years
measure: Determine feasibility of a pre-planned MR-only procedure
timeFrame: 5 years
measure: To determine the feasibility of an initial CT-only process by comparing initial and final CT plan dosimetry assessed by dosimetric indices, clinical tolerances, and statistical analysis (p-value).
timeFrame: 5 years
measure: Determine feasibility of optimising 3D-printed applicator design based on the cylinder fitting procedure
timeFrame: 5 years
measure: To measure resources such as procedure times and demonstrate acceptable timescales for the process
timeFrame: 5 years
measure: To define the resource costs associated with the 3D-printed design process and perform a cost comparison with the standard of care process
timeFrame: 5 years
measure: To assess patient experience and acceptability of the process with questionnaires
timeFrame: 5 years
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
Study officials:
affiliation: Royal North Shore Hospital
name: Marita Morgia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal North Shore Hospital
name: Jeremy Booth, PhD QMP
role: STUDY_DIRECTOR
References: