3DUS Imaging of Needles in Gynecological Brachytherapy

NCT04705467 | Recruiting

• 1 other identifier: 10812
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Gynecologic Cancer

Keywords

3D Ultrasound; Intervention

Outcome Measures

Primary Outcomes (1)

• Needle Localization Accuracy

  Observed needle locations in 3-D TVUS and CT planning images are measured and compared.

  16 Months

Study Arms (1)

Patients

OTHER

Device: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. 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.

Device: Gynecological brachytherapy

Interventions

Gynecological brachytherapy DEVICE

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.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Regional Cancer Program, Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

Central Study Contacts

David D'Souza, MD

CONTACT

519-685-8500; David.DSouza@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients who are assigned to gynecological brachytherapy

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: January 12, 2021
• Study Start: October 15, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)