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3D Ultrasound Microvessel Imaging for Breast Masses

Primary Purpose

Breast Carcinoma

Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electronic Health Record Review
Ultrasound Microvessel Imaging
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy.
  • Lesion size of 1 cm 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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (ultrasound microvessel imaging)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2021
Last Updated
August 28, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04925817
Brief Title
3D Ultrasound Microvessel Imaging for Breast Masses
Official Title
3D Ultrasound Microvessel Imaging for Breast Masses
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (ultrasound microvessel imaging)
Arm Type
Experimental
Arm Description
Patients undergo 3 D ultrasound microvessel imaging over 45 minutes. Patients' medical records are reviewed.
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Medical record reviewed
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Microvessel Imaging
Intervention Description
Undergo 3D ultrasound microvessel imaging
Primary Outcome Measure Information:
Title
Ultrasound diagnostic accuracy using McNemar's test
Description
Will be compared between conventional ultrasound (US) and conventional US + 3 dimensional (D) ultrasound microvessel imaging (UMI) using McNemar's test.
Time Frame
Up to 1 year
Title
Ultrasound parameters sensitivity using McNemar's test
Description
Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.
Time Frame
Up to 1 year
Title
Ultrasound parameters specificity using McNemar's test
Description
Diagnostic sensitivity comparison between conventional US versus US + 3D-UMIl using the McNemar's test. Scale = Max 100%, Min 0% - The higher, the better.
Time Frame
Up to 1 year
Title
Ultrasound parameters positive predictive value using McNemar's test
Description
Will include diagnostic performance parameters (positive predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Time Frame
Up to 1 year
Title
Ultrasound parameters negative predictive value using McNemar's test
Description
Will include diagnostic performance parameters (negative predictive value) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better. .
Time Frame
Up to 1 year
Title
Ultrasound parameters accuracy using McNemar's test
Description
Will include diagnostic performance parameters (accuracy) calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Time Frame
Up to 1 year
Title
Ultrasound parameters calculated by McNemar's test
Description
Will include Data System (BI-RADS) score calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Time Frame
Up to 1 year
Title
Ultrasound parameters vs. Breast Image Reporting using McNemar's test
Description
Will include Breast Imaging Reporting calculated based on the BI-RADS score. Scale = Max 100%, Min 0% - The higher, the better.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women with solid breast lesion who are scheduled for a clinically indicated ultrasound-guided biopsy. Lesion size of 1 cm 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shigao D Chen, Ph.D.
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

3D Ultrasound Microvessel Imaging for Breast Masses

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