Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2
- Conditions
- Gynecologic Cancer
- Interventions
- Device: Interstitial and intracavitary brachytherapy
- Registration Number
- NCT04336683
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 35
- Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary 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
- Above patients who are not offered interstitial or intracavitary brachytherapy as a treatment modality
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient Interstitial and intracavitary brachytherapy Patients undergoing gynecological brachytherapy, will be imaged with a 3D ultrasound medical device for the purpose of efficacy testing.
- Primary Outcome Measures
Name Time Method Efficacy of the 3DUS device to visualize applicators 16 Weeks The number of applicators identified within the 3D ultrasound image.
- Secondary Outcome Measures
Name Time Method 3DUS to CT Fusion 16 Weeks DICE coefficient of the tumour and needle applicators
Trial Locations
- Locations (1)
London Regional Cancer Program, Victoria Hospital
🇨🇦London, Ontario, Canada