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NCT04692818 Clinical Trial

3D Ultrasound Breast Imaging

Breast Tumor Clinical Trial

Official title:
3D Multimodal Ultrasound Imaging for Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04692818
Other study ID # 20-010751
Secondary ID W81XWH-21-1-0063
Status Recruiting
Phase N/A
First received
Last updated
Start date November 19, 2021
Est. completion date December 31, 2025

Study information
Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 125
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult women, = 18 years of age. - Breast lesion and are scheduled for clinically-indicated biopsy. Exclusion Criteria: - < 18 years of age. - Previous breast surgery or breast implant. - Lacking capacity to consent. - Pregnant or lactating. - Receiving cancer therapy such as chemotherapy or radiation therapy.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• GE Logiq E10 clinical ultrasound scanner
2D B-mode, Doppler, and shear wave elastography images of the lesion
• Verasonics research scanner
3D B-mode imaging, microvessel imaging, and shear wave elastography

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary BI-RADS Score 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. Baseline
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