Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

Gynecologic Cancer Clinical Trial

Official title:

Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336683
• Other study ID #: 106088
• Status: Completed
• Phase: N/A
• Start date: February 17, 2015
• Est. completion date: April 7, 2022

Study information

• Verified date: May 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 7, 2022
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
Canada	London Regional Cancer Program, Victoria Hospital	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Rodgers JR, Bax J, Surry K, Velker V, Leung E, D'Souza D, Fenster A. Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors. J Med — View Citation

Rodgers JR, Hrinivich WT, Surry K, Velker V, D'Souza D, Fenster A. A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors. Brachythera — View Citation

Rodgers JR, Mendez LC, Hoover DA, Bax J, D'Souza D, Fenster A. Feasibility of fusing three-dimensional transabdominal and transrectal ultrasound images for comprehensive intraoperative visualization of gynecologic brachytherapy applicators. Med Phys. 2021 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the 3DUS device to visualize applicators	The number of applicators identified within the 3D ultrasound image.	16 Weeks
Secondary	3DUS to CT Fusion	DICE coefficient of the tumour and needle applicators	16 Weeks