3D Ultrasound Microvessel Imaging for Breast Masses

Early Phase 1CompletedNCT04925817

Mayo Clinic50 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Carcinoma

Interventions

Electronic Health Record ReviewOTHER

Medical record reviewed

Ultrasound Microvessel ImagingPROCEDURE

Undergo 3D ultrasound microvessel imaging

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year

Ultrasound parameters sensitivity using McNemar's test

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

Time frame: 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.

Time frame: 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.

Time frame: 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. .

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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