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Clinical Trials/NCT04705467
NCT04705467
Recruiting
Not Applicable

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

Western University, Canada1 site in 1 country35 target enrollmentOctober 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gynecologic Cancer
Sponsor
Western University, Canada
Enrollment
35
Locations
1
Primary Endpoint
Needle Localization Accuracy
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2022
End Date
June 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Western University, Canada
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Needle Localization Accuracy

Time Frame: 16 Months

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

Study Sites (1)

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