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3D Ultrasound for Breast Tumor Diagnosis

This study is testing a new way to diagnose breast tumors using advanced ultrasound technology. Researchers are comparing two types of ultrasound scanners: the GE Logiq E10 clinical ultrasound scanner and the Verasonics research scanner. The Verasonics scanner uses 3D imaging, microvessel imaging, and shear wave elastography (a method to measure tissue stiffness). The goal is to see how well these new ultrasound methods can help doctors understand breast masses. You may be able to join if you are an adult woman (18 years or older) with a solid breast lesion (a lump or abnormality) that is 3mm or larger, and you are having an ultrasound-guided biopsy. We are looking for 125 participants for this study. The main way we will measure success is by looking at the BI-RADS Score (Breast Imaging Reporting and Data System), which is a standard way to describe breast imaging findings.

Study design
This is an interventional study, meaning participants will receive a specific diagnostic test. The study plans to enroll 125 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, BI-RADS Score, is measured at Baseline, so no long-term follow-up is specified.

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NCT04692818

3D Ultrasound Breast Imaging

Recruiting
NAAges 18+InterventionalHealth services
Mayo Clinic
~125 participants
Updated 2026-06-01 on ClinicalTrials.gov
What's tested:GE Logiq E10 clinical ultrasound scannerVerasonics research scanner

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
BI-RADS Score
Measured over Baseline

Conditions

Breast Tumor

Explore related trials

Breast Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Shigao Chen, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Christine Lee, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Bobbie Ott
[email protected]
507-293-0922
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • BI-RADS ScoreBaseline

    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.