Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

Western University, Canada

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Device: Interstitial and intracavitary brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04336683

106088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Patient

Other group

Description:

Patients undergoing gynecological brachytherapy, will be imaged with a 3D ultrasound medical device for the purpose of efficacy testing.

Treatment:

Device: Interstitial and intracavitary brachytherapy