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NCT03844399 Clinical Trial

(3D) Ultrasound Imaging Liver and Kidney

Liver Cancer Clinical Trial

Official title:
Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03844399
Other study ID # 6319
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 3, 2020
Est. completion date September 2024

Study information
Verified date October 2023
Source Western University, Canada
Contact Aaron Fenster
Phone 5199315777
Email afenster@uwo.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - • Patients who are scheduled for standard care liver or kidney ablation or biopsy Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Canada Victoria Hospital London Ontario

Sponsors (1)
Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Needle Guidance Intervention 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 April 2020
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