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

Breast Carcinoma Clinical Trial

Official title:

Breast Microcalcifications Identified With MicroPure as a Marker for Malignancy Compared to Grayscale Ultrasound and Mammography (Using Biopsy as the Reference Standard)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031561
• Other study ID #: 12D.17
• Status: Completed
• Phase: N/A
• First received: January 20, 2017
• Last updated: November 13, 2017
• Start date: March 1, 2012
• Est. completion date: March 10, 2016

Study information

• Verified date: November 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 10, 2016
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Calcinosis
• Microcalcification

Intervention

Device:
• Ultrasound
Undergo standard ultrasound
• MicoPure ultrasound
Undergo MicoPure ultrasound

Procedure:
• Biopsy of Breast
Undergo breast biopsy or surgical resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of microcalcifications seen on MicroPure ultrasound	The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.	Baseline
Primary	Number of microcalcifications seen on grayscale ultrasound	The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.	Baseline
Secondary	Number of microcalcifications determined by pathology findings	The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.	Baseline

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital