Liver CancerNCT03844399
(3D) Ultrasound Imaging Liver and Kidney
An observational study of Liver Cancer and Kidney Cancer, run by Western University, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Kidney Cancer
- What is being tested?
- Ablation and Biopsy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2020to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- • Patients who are scheduled for standard care liver or kidney ablation or biopsy
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital
London, Ontario, N6A 5W9
Derek Cool, MD/PhD, 5196858500 ext. 54965
About this study
Official title: Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies
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.
Read the 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.
- Conditions
- Liver Cancer, Kidney Cancer
- Being tested
- Ablation, Biopsy
- Keywords
- Diagnostic, Intervention, 3D Ultrasound
- Medical subject headings
- Liver Neoplasms, Kidney Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
The medical device will passively record image data during the standard care ablation
BiopsyDevice
The medical device will passively record image data during the standard care biopsy
| Study group | Role | What they receive |
|---|---|---|
| Patients | Cancer patients who are scheduled to undergo an ablation or biopsy of a liver or kidney tumour Receives: Device: Ablation; Device: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: April 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start3 Oct 2020
- Primary completionJul 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844399
- Sponsor's protocol ID
- 6319
- Status last verified
- Jul 2024
- First submitted
- 14 Feb 2019
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 3-Dimensional (3D) Ultrasound Imaging to Guide the Treatment of Abdominal Tumours Using Focal Ablation or Biopsies
- ClinicalTrials.gov ID
- NCT03844399
- Acronym / sponsor ID
- 6319
- Conditions
- Liver Cancer, Kidney Cancer
- Keywords
- Diagnostic, Intervention, 3D Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: Ablation, Device: BiopsyCancer patients who are scheduled to undergo an ablation or biopsy of a liver or kidney tumour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- • Patients who are scheduled for standard care liver or kidney ablation or biopsy
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationThe medical device will passively record image data during the standard care ablation | Device | Patients |
| BiopsyThe medical device will passively record image data during the standard care biopsy | Device | Patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer and Kidney Cancer, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Fenster (5199315777, afenster@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle Guidance Intervention (time frame: April 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.