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Trial Title:
3D Printed Custom Applicators for HDR BT (DISCO)
NCT ID:
NCT06432478
Condition:
Gynecologic Cancer
Endometrial Cancer
Vaginal Cancer
Vulva Cancer
Conditions: Official terms:
Endometrial Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Conditions: Keywords:
3D-printed applicator
Gynaecological Cancer
Brachytherapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
3D-printed custom applicator
Description:
3D-printed custom applicator
Arm group label:
Gynaecological HDR brachytherapy patients
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal North Shore Hospital
Address:
City:
St Leonards
Zip:
2067
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Carol Kwong
Phone:
02 9463 1339
Email:
Carolyn.Kwong@health.nsw.gov.au
Contact backup:
Last name:
Heidi Tsang
Phone:
02 9463 1340
Email:
Heidi.Tsang@health.nsw.gov.au
Start date:
November 24, 2023
Completion date:
September 2028
Lead sponsor:
Agency:
Royal North Shore Hospital
Agency class:
Other
Source:
Royal North Shore Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432478
