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Recruiting

NCT Number: NCT04692818

3D Ultrasound Breast Imaging

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

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Christine lee, MD, PhD

PRINCIPAL_INVESTIGATOR

Rica Pol

CONTACT

[email protected]

507-422-5118

Shigao Chen, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GE Logiq E10 clinical ultrasound scanner

Diagnostic Test

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

Verasonics research scanner

Diagnostic Test

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

Primary outcomes

  1. BI-RADS Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bobbie Ott

CONTACT

[email protected]

507-293-0922

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

3D Multimodal Ultrasound Imaging for Breast Cancer

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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