- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03861507
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
October 31, 2023 updated by: Aaron Fenster, Western University, Canada
This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance.
The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle.
The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aaron Fenster
- Phone Number: 5199315777 5199315777
- Email: afenster@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Recruiting
- Victoria Hospital
-
Contact:
- Douglas Hoover, PhD
- Email: Douglas.Hoover@lhsc.on.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male, aged 18 years or older
- Willing to provide written consent
- Pathologically confirmed prostate cancer on previous biopsy
- Suitable for and consenting to high-dose-rate brachytherapy for treatment as standard of care.
Exclusion Criteria:
- • Previous radiotherapy to the prostate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient
Patient undergoing standard care prostate high dose rate brachytherapy.
|
High dose - rate (HDR) brachytherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Needle Trajectory
Time Frame: 1 month following data collection
|
Intra-operative needle trajectories in B-mode and power Doppler ultrasound
|
1 month following data collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2020
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
February 28, 2019
First Submitted That Met QC Criteria
February 28, 2019
First Posted (Actual)
March 4, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 31, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6442
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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