3D Ultrasound Microvessel Imaging for Breast Masses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2023-05-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (ultrasound microvessel imaging)

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

Group Type EXPERIMENTAL

Electronic Health Record Review

Intervention Type OTHER

Medical record reviewed

Ultrasound Microvessel Imaging

Intervention Type PROCEDURE

Undergo 3D ultrasound microvessel imaging

Interventions

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Electronic Health Record Review

Medical record reviewed

Intervention Type OTHER

Ultrasound Microvessel Imaging

Undergo 3D ultrasound microvessel imaging

Intervention Type PROCEDURE

Other Intervention Names

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3D Ultrasound Microvessel Imaging UMI

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes