3D Ultrasound Breast Imaging

January 5, 2024 updated by: Shigao Chen, Mayo Clinic

3D Multimodal Ultrasound Imaging for Breast Cancer

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Shigao Chen, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult women, ≥ 18 years of age.
  • Breast lesion and are scheduled for clinically-indicated biopsy.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinically indicated breast tumor biopsy
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
2D B-mode, Doppler, and shear wave elastography images of the lesion
Diagnostic test: Verasonics research scanner
3D B-mode imaging, microvessel imaging, and shear wave elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Shigao Chen, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-010751
  • W81XWH-21-1-0063 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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