3D Printed Custom Applicators for HDR BT (DISCO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2028-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Individual Approach in Gynecological Cancer Brachytherapy

NCT03466957

Cancer

UNKNOWN NA

MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

NCT03634267

Human Papillomavirus-Related Carcinoma Human Papillomavirus-Related Cervical Carcinoma Stage IB2 Cervical Cancer AJCC v8 +14 more

ACTIVE_NOT_RECRUITING PHASE1

3DUS Imaging of Needles in Gynecological Brachytherapy

NCT04705467

Gynecologic Cancer

RECRUITING NA

Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

NCT03277469

Gynecologic Cancer

ACTIVE_NOT_RECRUITING NA

Vaginal Cuff Brachytherapy Fractionation Study

NCT03785288

Endometrial Cancer

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Cancer Endometrial Cancer Vaginal Cancer Vulva Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gynaecological HDR brachytherapy patients

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

Group Type EXPERIMENTAL

3D-printed custom applicator

Intervention Type DEVICE

3D-printed custom applicator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

3D-printed custom applicator

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No