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Recruiting NCT04705467

3DUS Imaging of Needles in Gynecological Brachytherapy

No phase Interventional Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gynecological brachytherapy.
Who it may be relevant to
Registry conditions: Gynecologic Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Needle Localization Accuracy [Time frame: 16 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Canada · 1 center
  • London Regional Cancer Program, Victoria Hospital — London

Identifiers

NCT: NCT04705467 · 10812

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗