Comparison of 3D Ultrasound and Standard Imaging for Breast Assessment
Official title: Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
Run by Western University, Canada · NCT06118996 · Data updated 2026-11-12
This study is testing whether a new 3D ultrasound can see breast tumors better than the standard 2D ultrasound in women getting routine breast exams.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Status | Recruiting |
| Started | August 18, 2024 |
| Main results expected | April 2026 |
| Study ends | December 2026 |
| Registry record updated | April 13, 2025 |
| Trial ID | NCT06118996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult females scheduled for screening or short-term follow-up with automated breast ultrasound (ABUS).
✕Probably not a fit
Patients with breast implants or those who cannot tolerate ABUS may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the effectiveness of a customized 3D ultrasound device against the standard 2D ultrasound in visualizing breast tumors and features. It will recruit 30 female participants who are scheduled for routine mammography and ultrasound assessments. During the procedure, additional 3D ultrasound images will be captured to evaluate their diagnostic capabilities. The study is led by Dr. Aaron Fenster at Western University, utilizing a commercial ultrasound machine adapted for 3D imaging.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of breast cancer detection and improve patient outcomes.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving imaging techniques for breast assessment.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult Patients who are scheduled for screening ABUS * Adults Patients who are scheduled for short term follow-up with ABUS. * Must be at least 18 years of age or older. * Must be proficient in English (reading/writing). Exclusion Criteria: * Patients with breast implants. * Patients with contraindication for ABUS. * Patients who cannot tolerate ABUS.
Where it's running
-
St. Joseph's Hospital
London, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Anat Kornecki, MD
- Email: Anat.Kornecki@sjhc.london.on.ca
- Phone: 519-646-6100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.