3DUS Imaging of Needles in Gynecological Brachytherapy

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer
• Interventions: Device: Gynecological brachytherapy

• Registration Number: NCT04705467
• Lead Sponsor: Western University, Canada

Brief Summary

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. We propose using 3D ultrasound to provide real-time imaging for the brachytherapy procedure, which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Study Start: 2022-10-15
• Status Verified: 2024-11
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-10
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

• Females of age eighteen (18) or greater.
• Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas

Exclusion Criteria

• Above patients who are not offered interstitial brachytherapy as a treatment modality

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Gynecological brachytherapy	Device: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning.

Primary Outcome Measures

Name	Time	Method
Needle Localization Accuracy	16 Months	Observed needle locations in 3-D TVUS and CT planning images are measured and compared.

Trial Locations

Locations (1)

London Regional Cancer Program, Victoria Hospital; 🇨🇦 London, Ontario, Canada