Comparison of 3D Ultrasound and Standard Imaging for Breast Assessment
Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University, Canada Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06118996 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult females scheduled for screening or short-term follow-up with automated breast ultrasound (ABUS).
Not a fit: Patients with breast implants or those who cannot tolerate ABUS may not benefit from this study.
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 performed: While this approach is innovative, similar studies have shown promise in improving imaging techniques for breast assessment.
Eligibility criteria
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 this trial is running
London, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.