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Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03861507
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Aaron Fenster, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Prostate Brachytherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Needle Localization During Prostate Brachytherapy Using Power Doppler Ultrasound
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Patient
Patient undergoing standard care prostate high dose rate brachytherapy.
Device: Prostate Brachytherapy
High dose - rate (HDR) brachytherapy




Primary Outcome Measures :
  1. Needle Trajectory [ Time Frame: 1 month following data collection ]
    Intra-operative needle trajectories in B-mode and power Doppler ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861507


Contacts
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Contact: Aaron Fenster 5199315777 ext 5199315777 afenster@uwo.ca

Locations
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Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Douglas Hoover, PhD       Douglas.Hoover@lhsc.on.ca   
Sponsors and Collaborators
Western University, Canada
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Responsible Party: Aaron Fenster, Medical Biophysics Professor, Western University, Canada
ClinicalTrials.gov Identifier: NCT03861507    
Other Study ID Numbers: 6442
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases