3D Ultrasound Breast Imaging

Not Applicable

Recruiting

• Conditions: Breast Tumor
• Interventions: Diagnostic Test: GE Logiq E10 clinical ultrasound scanner; Diagnostic Test: Verasonics research scanner

• Registration Number: NCT04692818
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Start: 2021-11-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 125

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinically indicated breast tumor biopsy	GE Logiq E10 clinical ultrasound scanner	Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed
Clinically indicated breast tumor biopsy	Verasonics research scanner	Subjects with breast lesion and are scheduled for clinically-indicated biopsy will have 3D Multimodal Ultrasound Imaging performed

Primary Outcome Measures

Name	Time	Method
BI-RADS Score	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States