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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Microcalcification; Breast Carcinoma

Treatments: Device: MicoPure ultrasound; Procedure: Biopsy of Breast; Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03031561

12D.17

JT 1962 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 85 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Is clinically unstable, severely ill, or moribund

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Diagnostic (standard ultrasound, MicroPure, biopsy)

Experimental group

Description:

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.

Treatment:

Device: Ultrasound

Procedure: Biopsy of Breast

Device: MicoPure ultrasound