3D Ultrasound Breast Imaging

Mayo Clinic

Status: Enrolling

Conditions: Breast Tumor

Treatments: Diagnostic Test: Verasonics research scanner; Diagnostic Test: GE Logiq E10 clinical ultrasound scanner

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04692818

W81XWH-21-1-0063 (Other Grant/Funding Number)

20-010751

Details and patient eligibility

About

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

Enrollment: 125 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Clinically indicated breast tumor biopsy

Experimental group

Description:

Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed

Treatment:

Diagnostic Test: GE Logiq E10 clinical ultrasound scanner

Diagnostic Test: Verasonics research scanner