3D Ultrasound Microvessel Imaging for Breast Masses

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: Breast Carcinoma
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Ultrasound Microvessel Imaging

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

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	Will include diagnostic performance parameters (sensitivity) calculated based on the BI-RADS score.	Up to 1 year
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.	Up to 1 year
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.	Up to 1 year
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. .	Up to 1 year
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.	Up to 1 year
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.	Up to 1 year
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.	Up to 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Shigao Chen, Ph.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

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: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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