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Completed

NCT Number: NCT04336683

Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

London Regional Cancer Program, Victoria Hospital

London, Ontario, N6A 5W9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interstitial and intracavitary brachytherapy

Device

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

Primary outcomes

  1. Efficacy of the 3DUS device to visualize applicators

    Time frame: 16 Weeks

    The number of applicators identified within the 3D ultrasound image.

Secondary outcomes

  1. 3DUS to CT Fusion

    Time frame: 16 Weeks

    DICE coefficient of the tumour and needle applicators

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Apr 7, 2020
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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