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Brachytherapy
3D Ultrasound-Guided Brachytherapy for Gynecologic Cancers
N/A
Recruiting
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 months
Awards & highlights
Study Summary
This trial is testing whether 3D ultrasound can help guide needles during a cancer treatment called brachytherapy, to improve the accuracy of the treatment and spare healthy tissue.
Who is the study for?
This trial is for women aged 18 or older with advanced or recurrent gynecological cancers, such as vaginal, endometrial, or cervical cancers. It's specifically for those who are recommended to receive interstitial or ring and tandem brachytherapy treatments.Check my eligibility
What is being tested?
The study tests the use of real-time 3D ultrasound imaging during brachytherapy procedures in gynecologic cancer treatment. The goal is to improve needle placement accuracy and avoid damage to pelvic organs while ensuring the tumor receives an optimal dose.See study design
What are the potential side effects?
While not explicitly listed, side effects may include discomfort from the ultrasound procedure, potential risks associated with inaccurate needle placement if technology fails, and general risks related to brachytherapy like tissue irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced or recurrent cancer in my reproductive organs and am offered a specific radiation treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Needle Localization Accuracy
Trial Design
1Treatment groups
Experimental Treatment
Group I: PatientsExperimental Treatment1 Intervention
Device: Gynecological brachytherapy requiring an Interstitial or ring and tandem insert involves insertion of the needle and applicators with no standard real-time image guidance. Occasionally 2-dimensional ultrasound is used, but it greatly limited by its flat nature, preventing a volumetric view of the needle pathways. Interstitial brachytherapy is done under general anesthesia. The trans-abdominal and trans-rectal standard 2D ultrasound that are used in some cases, will be expanded to 3D dimensional imaging through the use of an investigational device. 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.
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Who is running the clinical trial?
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,418 Total Patients Enrolled
1 Trials studying Gynecologic Cancers
35 Patients Enrolled for Gynecologic Cancers
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman aged 18 or older.I am not being considered for internal radiation treatment.I have advanced or recurrent cancer in my reproductive organs and am offered a specific radiation treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being enrolled in this clinical trial at this time?
"According to the latest information on clinicaltrials.gov, this particular trial is no longer recruiting patients. The listing was created on June 15th 2021 and edited as recently as April 26th 2021. Although this study has completed recruitment, there are many other opportunities available; currently, 75 other trials are actively looking for participants."
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