FIELD OF THE INVENTION

The present invention generally relates to the field of medical imaging of the breast, and in particular, to the methods of documenting breast tissue in a subject in need thereof using automated breast ultrasound.

BACKGROUND OF THE INVENTION

Breast mammography has become the standard diagnostic breast screening tool in women's healthcare, aiding in the detection and intervention of early-stage breast cancers. However, despite favorable research, mammography alone has not been effective in all populations of women and is most notably less sensitive in women who have dense breast tissue. Dense breast tissue obscures tumors on mammograms, making it difficult for radiologists to read and interpret the exams. This inaccuracy has resulted in an increased number of false negatives that lead to missed diagnosis of an existing cancer, and has increased healthcare costs and patient anxiety.

For this reason, and the fact that women with dense breast tissue are at an increased risk for developing breast cancer, supplemental imaging tests have become popular, including ultrasound imaging. However, there are limitations to using traditional hand-held ultrasound that have prevented the technology from being used more extensively in supplemental breast imaging for women with dense breast tissue. The length of traditional ultrasound tests is one drawback, as it can take up to 30 minutes to complete the exam. Another issue that handheld ultrasound screening presents is operator dependency. The results obtained in an ultrasound exam are highly dependent on the skill and expertise of the operator. Further, results obtained using handheld ultrasound are difficult to compare year after year, as only 5 images of each breast (one per quadrant and the subareolar breast) are saved in a typical exam.

3D Supine Automated Ultrasound (3D SAUS) technology addresses the shortcomings of traditional ultrasound. Like traditional ultrasound, 3D SAUS uses high-frequency sound waves targeted at the breast, but the scans are automatically acquired in a short period with no or minimal operator input, thereby greatly reducing operator dependency. Further, 3D SAUS provides physicians with an ultrasonic three-dimensional (3-D) volumetric image of the entire breast, allowing experts the ability to document the breast from a variety of angles and offer unambiguous analysis, with the added ability to perform year to year comparison of imaging results.

Despite these advantages, challenges in documenting an area of interest when an automated system is used remain. In breast imaging, it is important to designate a palpable or painful area for the radiologist to document the correct area and to record the information for the patient's record. Using traditional ultrasonography, only the area of interest is imaged, and the tissue of interest is marked on the images by the sonologist or physician performing a handheld evaluation. In non-operator dependent 3D SAUS imaging, an operator cannot designate the area of interest, and the sonologist or physician cannot then document the correct area.

Therefore, there is a need in the medical field of breast imaging for a method of designating an area of interest in breast tissue for later analysis and diagnosis of the palpable and/or painful area.

SUMMARY OF THE INVENTION

One aspect of the present disclosure encompasses a method of documenting breast tissue of interest in a subject in need thereof using automated breast ultrasound. The method comprises placing a marker having a flat configuration with an upper side and a lower side at the surface of the breast at a location designating the breast tissue of interest, wherein the lower side of the marker is in contact with the surface of the breast. The method further comprises acquiring an ultrasonic 3-D volumetric image of the breast by applying sound waves to the breast including the marker and the breast tissue of interest; identifying a sonographic outline of the marker at the surface of the breast in the acquired image, wherein the outline results from artifacts produced by the marker of a portion of the sound waves applied to the breast; identifying the breast tissue of interest in the image in reference to the outline of the marker at the surface of the breast, wherein the tissue of interest is breast tissue underlying the surface of the breast at the location of the marker; and documenting the breast tissue of interest.

The tissue of interest can comprise a palpable mass, and the subject can be a human with dense breast tissue. The intensity of the outline of the marker at the surface of the breast in the acquired image can be of uniform intensity. Further, the artifact can result in an area of increased brightness in the acquired image.

The marker can comprise material uniformly distributed throughout the marker. The tissue of interest can be substantially free of artifacts in the image. The configuration of the marker can comprise material, width, and thickness. The material can be plastic material, the width of the marker can range from about 0.3 cm to about 1 cm, and the thickness of the marker ranges from about 0.5 mm to about 2 mm. In some aspects, the marker is in the form of a circle, and the diameter of the circle ranges from about 0.3 cm to about 1 cm. The marker can be free of openings, bends, curves, lumps, indentations, or irregularities. The marker can further comprise means for retaining the marker in a fixed position at the surface of the breast.

Another aspect of the present disclosure encompasses a method of using a surface marker for documenting a palpable mass in breast tissue in an area of interest of a subject in need thereof using automated breast ultrasound. The method comprises placing a plastic marker having a flat configuration with an upper side and a lower side, a width ranging from about 0.3 cm to about 1 cm, and a thickness ranging from about 0.5 mm to about 2 mm, at the surface of the breast at a location designating the breast tissue of interest, wherein the lower side of the marker is in contact with the surface of the breast. The method further comprises acquiring an ultrasonic 3-D volumetric image of the breast by applying sound waves to the breast including the marker and the breast tissue of interest; identifying a sonographic outline of the marker at the surface of the breast in the acquired image, wherein the outline of the marker results from artifacts produced by the marker of a portion of the sound waves applied to the breast; identifying the breast tissue of interest in the image in reference to the outline of the marker at the surface of the breast, wherein the tissue of interest is breast tissue underlying the surface of the breast at the location of the marker; and documenting the breast tissue of interest.

Yet another aspect of the present disclosure encompasses a method of using a surface marker for documenting a palpable mass in breast tissue in an area of interest of a subject in need thereof using automated breast ultrasound. The method comprises placing a circular plastic marker having a flat configuration with an upper side and a lower side, a diameter ranging from about 0.3 cm to about 1 cm, and a thickness ranging from about 0.5 mm to about 2 mm, at the surface of the breast at a location designating the breast tissue of interest, wherein the lower side of the marker is in contact with the surface of the breast. The method further comprises acquiring an ultrasonic 3-D volumetric image of the breast by applying sound waves to the breast including the marker and the breast tissue of interest; identifying a sonographic outline of the marker at the surface of the breast in the acquired image, wherein the outline of the marker results from artifacts produced by the marker of a portion of the sound waves applied to the breast; identifying the breast tissue of interest in the image in reference to the outline of the marker at the surface of the breast, wherein the tissue of interest is breast tissue underlying the surface of the breast at the location of the marker; and documenting the breast tissue of interest.

Other aspects and features of the disclosure are described more thoroughly below.

REFERENCE TO COLOR FIGURES

The application file contains at least one photograph executed in color. Copies of this patent application publication with color photographs will be provided by the Office upon request and payment of the necessary fee.

