NCT04336683

Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is 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. The investigators propose a 3D ultrasound device that will 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

This is an efficacy study to optimize the use of three-dimensional ultrasound imaging for interstitial and intracavitary brachytherapy. In this study, 3DUS images will be acquired during the regular clinical procedure to assess the quality of the images, anatomical detail and location of needles. The acquired images will be analyzed post-treatment and fused with pre-treatment MRI, and post-treatment CT scans to develop a virtual simulated radiation treatment plan, and to verify the applicator positions.

Conditions

• Gynecologic Cancer

Interventions

Type	Name	Description
DEVICE	Interstitial and intracavitary brachytherapy	Standard of care in interstitial or intracavitary brachytherapy is to insert the brachytherapy needle and applicator with no standard real-time image guidance. Interstitial brachytherapy is done under general anesthesia. Trans-abdominal and trans-rectal standard 2D ultrasound is used in some cases, but is typically not consistent and therefore its value is limited. 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

Timeline

• Start date: 2015-02-17
• Primary completion: 2021-06-15
• Completion: 2022-04-07
• First posted: 2020-04-07
• Last updated: 2023-05-17

Locations

1 site across 1 country: Canada