search
Back to results

Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prostate Brachytherapy
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Victoria HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient

Arm Description

Patient undergoing standard care prostate high dose rate brachytherapy.

Outcomes

Primary Outcome Measures

Needle Trajectory
Intra-operative needle trajectories in B-mode and power Doppler ultrasound

Secondary Outcome Measures

Full Information

First Posted
February 28, 2019
Last Updated
August 8, 2022
Sponsor
Western University, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT03861507
Brief Title
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
Official Title
Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2020 (Actual)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient
Arm Type
Other
Arm Description
Patient undergoing standard care prostate high dose rate brachytherapy.
Intervention Type
Device
Intervention Name(s)
Prostate Brachytherapy
Intervention Description
High dose - rate (HDR) brachytherapy
Primary Outcome Measure Information:
Title
Needle Trajectory
Description
Intra-operative needle trajectories in B-mode and power Doppler ultrasound
Time Frame
1 month following data collection

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aaron Fenster
Phone
5199315777
Ext
5199315777
Email
afenster@uwo.ca
Facility Information:
Facility Name
Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas Hoover, PhD
Email
Douglas.Hoover@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

We'll reach out to this number within 24 hrs