3D Multimodal Ultrasound Imaging for Breast Cancer

Mayo Clinic1 site in 1 country125 target enrollmentNovember 10, 2021

ConditionsBreast Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Tumor
Sponsor: Mayo Clinic
Enrollment: 125
Locations: 1
Primary Endpoint: BI-RADS Score
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to study the efficacy of a new ultrasound imaging method for diagnosis of breast mass.

Registry

clinicaltrials.gov

Start Date

November 10, 2021

End Date

December 31, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Mayo Clinic

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult women ≥ 18 years of age.
•solid breast lesion and ultrasound guided biopsy (either as part of their clinical care or through participation in other IRB-approved studies)
•lesion size of 3mm or larger

Exclusion Criteria

•\< 18 years of age.
•Lacking capacity to consent
•Pregnant or lactating
•Receiving cancer therapy such as chemotherapy or radiation therapy

Outcomes

Primary Outcomes

BI-RADS Score

Time Frame: Baseline

BI-RADS scores will be obtained using 2D B-mode ultrasound images from the GE Logiq E10 clinical scanner, and using 3D B-mode images from the Verasonics scanner. A 7-point BI-RADS scale will be used, with a score of 1, 2, or 3 considered negative and 4a, 4b, 4c, and 5 considered positive.