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Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2

NCT04336683 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-05-17

No results posted yet for this study

Summary

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.

Conditions

  • Gynecologic Cancer

Interventions

DEVICE

Interstitial and intracavitary brachytherapy

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

Sponsors & Collaborators

  • Western University, Canada

    lead OTHER

Principal Investigators

  • David D'Souza, MD · Schulich School of Medicine and Dentistry

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-17
Primary Completion
2021-06-15
Completion
2022-04-07

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336683 on ClinicalTrials.gov