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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04705467
Other study ID # 10812
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 15, 2022
Est. completion date June 2025

Study information

Verified date November 2023
Source Western University, Canada
Contact David D'Souza, MD
Phone 519-685-8500
Email David.DSouza@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date June 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Canada London Regional Cancer Program, Victoria Hospital London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Needle Localization Accuracy Observed needle locations in 3-D TVUS and CT planning images are measured and compared. 16 Months
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