3D Ultrasound Microvessel Imaging for Breast Masses

June 6, 2024 updated by: Mayo Clinic
This early phase I trial studies how well 3D ultrasound microvessel imaging works for the diagnosis of breast mass. The 3D ultrasound microvessel imaging technology demonstrates significantly increased vessel detection sensitivity over conventional doppler methods without the need of using contrast agents. This study may improve cancer diagnosis and reduce unnecessary biopsy on benign tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Optimization of imaging protocol for this new ultrasound technology. II. Investigate the diagnostic performance of the new ultrasound technology using clinically indicated biopsy as the reference standard.

OUTLINE:

Patients undergo 3 dimensional (D) ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Early Phase 1

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
        • Mayo Clinic in Rochester

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

Yes

Description

Inclusion Criteria:

  • Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
  • Lesion size of 3 mm or larger.
  • Age 18 or greater.

Exclusion Criteria:

  • Women with previous breast surgery or breast implant.
  • Lacking the capacity to consent.
  • Women who are pregnant or lactating.
  • Women who are 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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (ultrasound microvessel imaging)
Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
Other: Electronic Health Record Review
Medical record reviewed
Procedure: Ultrasound Microvessel Imaging
Undergo 3D ultrasound microvessel imaging
Other Names:
  • 3D Ultrasound Microvessel Imaging
  • UMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound diagnostic accuracy using McNemar's test
Time Frame: Up to 1 year
Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Up to 1 year
Ultrasound parameters sensitivity using McNemar's test
Time Frame: Up to 1 year
Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
Up to 1 year
Ultrasound parameters specificity using McNemar's test
Time Frame: Up to 1 year
Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Up to 1 year
Ultrasound parameters positive predictive value using McNemar's test
Time Frame: Up to 1 year
Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Up to 1 year
Ultrasound parameters negative predictive value using McNemar's test
Time Frame: Up to 1 year
Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Up to 1 year
Ultrasound parameters accuracy using McNemar's test
Time Frame: Up to 1 year
Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Up to 1 year
Ultrasound parameters calculated by McNemar's test
Time Frame: Up to 1 year
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Up to 1 year
Ultrasound parameters vs. Breast Image Reporting using McNemar's test
Time Frame: Up to 1 year
Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Up to 1 year

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

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

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)

August 19, 2021

Primary Completion (Actual)

May 18, 2023

Study Completion (Actual)

May 18, 2023

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 11, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-002713 (Other Identifier: Mayo Clinic Institutional Review Board)
  • P30CA015083 (U.S. NIH Grant/Contract)
  • NCI-2021-04853 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R03CA241020 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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