3D Ultrasound Breast Imaging

NCT04692818 | Recruiting FDA Device

• 2 other identifiers: 20-010751W81XWH-21-1-0063
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Tumor

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Clinically indicated breast tumor biopsy

EXPERIMENTAL

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

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

Interventions

GE Logiq E10 clinical ultrasound scanner DIAGNOSTIC_TEST

2D B-mode, Doppler, and shear wave elastography images of the lesion

Clinically indicated breast tumor biopsy

Verasonics research scanner DIAGNOSTIC_TEST

3D B-mode imaging, microvessel imaging, and shear wave elastography

Clinically indicated breast tumor biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• United States Department of Defense: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shigao Chen, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Christine Lee, MD, PhD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bobbie Ott

CONTACT

507-293-0922; Ott.Bobbie@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: November 10, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)