3DUS Imaging of Needles in Gynecological Brachytherapy

Gynecologic Cancer Clinical Trial

Official title:

A Multi-Modality Comparison of Needle Placement During Gynecological Brachytherapy Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705467
• Other study ID #: 10812
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: June 2025

Study information

• Verified date: November 2023
• Source: Western University, Canada
• Contact: David D'Souza, MD
• Phone: 519-685-8500
• Email: David.DSouza[@]lhsc.on.ca
• 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 or intra-cavitary brachytherapy are often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial or intra-cavitary brachytherapy are 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. We propose using 3D ultrasound to 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: June 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Females of age eighteen (18) or greater.

• Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or ring and tandem 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 brachytherapy as a treatment modality

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

Device:
• Gynecological brachytherapy
Management of gynecological malignancies is done through brachytherapy treatment, which involves the delivery of radiation via radioactive sources that are placed into or in close proximity to the tumour.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle Localization Accuracy	Observed needle locations in 3-D TVUS and CT planning images are measured and compared.	16 Months