NCT03844399

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2020Feb 2027

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 3, 2020

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 20, 2025

Status Verified

July 1, 2024

Enrollment Period

5.7 years

First QC Date

February 14, 2019

Last Update Submit

July 16, 2025

Conditions

Keywords

DiagnosticIntervention3D Ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients

Cancer patients who are scheduled to undergo an ablation or biopsy of a liver or kidney tumour

Device: AblationDevice: Biopsy

Interventions

AblationDEVICE

The medical device will passively record image data during the standard care ablation

Patients
BiopsyDEVICE

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

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Liver NeoplasmsKidney NeoplasmsDisease

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Aaron Fenster

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

October 3, 2020

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 20, 2025

Record last verified: 2024-07

Locations