Clinical pilot study of 3D-cup ultrasound of the breast

X-ray mammography is of limited use in screening for breast cancer in young
women (with often dense breasts). Mammography is often painful due to
compression of the breasts and it makes use of radiation. There is therefore a
need for a noninvasive, harmless method for screening for breast cancer in
young women at risk for developing breast cancer. Thus far the role of
ultrasound (US) in screening is disputable since with conventional 2D US it is
difficult to convincingly image the entire breast. The proposed automated 3D
method will make breast US largely investigator-independent and probably more
reproducible.

a) to analyze and optimize the image quality of this prototype 3D-scanner.
b) to assess the potential of the 3D-scanner to detect lesions (benign and
malignant) in the breast and
c) to assess the potential to determine the localization of lesions in the
breast relative to skin, nipple, and axilla.

Patients with abnormalities in the breast at conventional 2D ultrasound will be
asked to participate in the study. A 3D-cup ultrasound examination of both
breasts will be made. After reconstruction of the 3D images, image quality,
visualization of anatomic landmarks in the breasts will be assessed and the
presence of lesions will be recorded. The images will be compared with the
conventional 2D-examination.

Ultrasound of the breast is harmless with little discomfort for the patients.
The only difference for the patients is that 3D is performed in the prone
position and 2D in supine position.
In the cupidus-3D protocol the patient has to remain in prone position for 20
min on a table with her breast hanging in a cup (10 minutes per breast).