3DUS Imaging of Needles in Gynecological Brachytherapy

Sponsor
Western University, Canada
Study ID
NCT04705467
Status
Recruiting
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Conditions

  • Gynecologic Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jan 12, 2021
Start date
Oct 15, 2022
Status verified
Nov 2024
Primary completion
Oct 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Patients
    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.

Primary Outcome Measure

Needle Localization Accuracy [ Time Frame: 16 Months ]

Central Contacts

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