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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06118996
Other study ID # 14144
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date December 2026

Study information

Verified date April 2024
Source Western University, Canada
Contact Anat Kornecki, MD
Phone 519-646-6100
Email Anat.Kornecki@sjhc.london.on.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date December 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
3D Ultrasound Image Acquisition
A custom device will be used with a clinical ultrasound machine to acquire ultrasound images of the breast.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Outcome

Type Measure Description Time frame Safety issue
Primary Breast Images Images of the breast anatomy will be compared to standard of care imaging. 24 months
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