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(3D) Ultrasound Imaging Liver and Kidney

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: NCT03844399
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Study Description
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Brief Summary:
This study is to assess the addition of 3D ultrasound guidance during standard care ablation or biopsies of liver or kidney tumours. 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-demensional volume , allowing area in question to be viewed in many different planes. 3D ultrasound is a safe, fast, non-invasive imaging procedure. Ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed or properly targeted during biopsy.

Condition or disease Intervention/treatment
Liver Cancer Kidney Cancer Device: Ablation Device: Biopsy

Detailed Description:
Images will be acquired by a physician on patients who are undergoing a liver or kidney ablation or biopsy procedure who are well enough to provide consent. Patients will be imaged during the ablation procedure according to the standard of care, and subsequent analysis will commence following the acquisition. The devices being used are all property of the LHSC health network that have been licensed for clinical use through Health Canada. In addition, 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-dimensional volume, allowing the area in question to be viewed in different planes. The clinical 2D an d3D ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed.
Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies
Actual Study Start Date : October 3, 2020
Estimated Primary Completion Date : April 6, 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients
Cancer patients who are scheduled to undergo an ablation or biopsy of a liver or kidney tumour
 Device: Ablation
The medical device will passively record image data during the standard care ablation

Device: Biopsy
The medical device will passively record image data during the standard care biopsy


Outcome Measures
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Primary Outcome Measures :
  1. Needle Guidance Intervention [ Time Frame: April 2020 ]
    The objective of this study is to use 3D ultrasound in addition to standard care ultrasound to guide the ablation needles in destroying focal tumours within the diseased organ


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who meet the inclusion / exclusion criteria, who are already scheduled for a liver or kidney tumour ablation or biopsy will be selected for the study.
Criteria

Inclusion Criteria:

  • • Patients who are scheduled for standard care liver or kidney ablation or biopsy

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT03844399


Contacts
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Contact: Aaron Fenster 5199315777 afenster@uwo.ca

Locations
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Canada, Ontario
Victoria Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Derek Cool, MD/PhD    5196858500 ext 54965      
Sponsors and Collaborators
Western University, Canada
More Information
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03844399    
Other Study ID Numbers: 6319
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
Diagnostic
Intervention
3D Ultrasound
Additional relevant MeSH terms:
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Kidney Neoplasms
Neoplasms by Site
Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Kidney Diseases
Urologic Diseases