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NCT Number: NCT04705467

3DUS Imaging of Needles in Gynecological Brachytherapy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

London Regional Cancer Program, Victoria Hospital

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

Location contact

David D'Souza, MD

CONTACT

[email protected]

519-685-8500 ext. 53601

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Needle Localization Accuracy

    Time frame: 16 Months

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

Study contacts

Contact information is provided by the study sponsor or research team.

David D'Souza, MD

CONTACT

[email protected]

519-685-8500 ext. 53601

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2021
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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