Ultrasound Imaging Technique in Detecting Breast Microcalcifications in Patients Undergoing Biopsy for a Breast Abnormality

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

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-01

Study Completion Date

2016-03-10

Brief Summary

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This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.

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Detailed Description

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PRIMARY OBJECTIVES:

I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.

SECONDARY OBJECTIVES:

I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).

II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.

III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.

Conditions

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Breast Carcinoma Microcalcification

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Diagnostic (standard ultrasound, MicroPure, biopsy)

Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Undergo standard ultrasound

MicoPure ultrasound

Intervention Type DEVICE

Undergo MicoPure ultrasound

Biopsy of Breast

Intervention Type PROCEDURE

Undergo breast biopsy or surgical resection

Interventions

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Ultrasound

Undergo standard ultrasound

Intervention Type DEVICE

MicoPure ultrasound

Undergo MicoPure ultrasound

Intervention Type DEVICE

Biopsy of Breast

Undergo breast biopsy or surgical resection

Intervention Type PROCEDURE

Other Intervention Names

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Ultrasound Imaging US Breast Biopsy

Eligibility Criteria

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Inclusion Criteria

* Give written informed consent
* Be scheduled for a sonographic or stereotactic guided core needle biopsy or surgical excision for the evaluation of a breast lesion or abnormality containing microcalcifications seen on mammography