Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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.

More Breast Diseases trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorWestern University, Canada
Academic / other
Locations1 site (London, Ontario)
StatusRecruiting
StartedAugust 18, 2024
Main results expectedApril 2026
Study endsDecember 2026
Registry record updatedApril 13, 2025
Trial IDNCT06118996 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.