This study was a prospective clinical trial conducted from January 2016 to July 2016.
A total of 52 consecutive female patients [50.4-60.0 (mean 54.5±2.5) years of age],
who attended Astana City Oncologic Center within the framework of the Kazakhstan mammography screening program and fulfilled the inclusion criteria: voluntary participation in the breast cancer screening program; no history of previous breast cancer; screening mammography findings rated as BI-RADS 4; the presence of visible on mammogram microcalcifications without associated breast mass; and available histopathology as a reference standard,
were included in this analysis.
All patients enrolled in the present study were classified as BI-RADS 4 and hence were referred for further evaluation by breast ultrasound and stereotactic core biopsy.
All patients provided written informed consent and the study was approved by the Medical University Astana Institutional Review Board.
The authors declare no conflict of interest.
Mammography.
Digital mammography was performed as a first step of evaluation.
Standardized cranio-caudal and medio-lateral oblique images of both breasts were obtained,
assessed by two experienced breast radiologists.
Parameters for evaluation of microcalcifications were: distribution of microcalcifications: clustered,
linear,
segmental; shape of microcalcifications: round,
punctuate,
amorphous,
heterogeneous,
linear branching; quantity of microcalcification per squared centimeter.
Ultrasound
All enrolled patients underwent ultrasound of the area in the breast where calcifications were seen with mammography.
The Aplio 400 scanner with a 12-MHz broad-bandwidth linear array was used to perform gray scale ultrasound and “MicroPure” imaging.
Sagittal and transverse still images were obtained in all patients.
The evaluation of the ultrasound images was performed by the same breast radiologist who evaluated the digital mammography,
using the following parameters: quality of the microcalcification visibility on a 4-point scale: well visible,
fairly visible,
poorly visible,
not visible.
Categorizing lesions as “poorly visible” and “not visible” was considered negative result.
Standard of reference.
Digital mammography served as the standard of reference for the detection of microcalcifications by ultrasound.
Histopathology served as the standard of reference for the final diagnosis.
All patients underwent stereotactic core biopsy using Bard Magnum system with a 14-gauge needle.
All histopathological specimens were evaluated by two pathologists specialized in oncological pathology.
Diagnoses were made in consensus.
Statistical analysis.
Statistical analysis was performed using R-statistical software.
Sensitivity and specificity of the “MicroPure” technique was calculated for all microcalcifications and for different types of microcalcifications.
A p-value of less than 0.05 indicated significance for each test.