Fig 1.
MammoWave system, sketch of the breast imaging configuration showing the cylindrical hub and the antennas (left). Transmitting and receiving antenna configuration, showing the five triplet sections (right).
Fig 2.
Clinical trial’s workflow of the second phase.
Prior to the kick-off of the second phase, 15 participants in each centre, all having NF breasts, have been examined by MammoWave and data has been used to calibrate the image parameters’ thresholds. MammoWave images were reviewed by a central assessor (an independent external scientist), who had no access to the reference standard data; the central assessor discarded MammoWave outputs due to the presence of spurious peaks in MammoWave images. Subsequently, the microwave imaging output of MammoWave is compared to the output of the radiologist study review (from conventional exams).
Table 1.
Summary of radiological study review.
Table 2.
Radiologist study review’s finding typology and final BI-RADS assessment.
Table 3.
Calculated mean, standard deviation, Welch’s t-test score and p-value and the AUC for all the selected features.
In the left column, we indicate the names of the features preceded by the names of the corresponding methods (where m1 indicates method1, m2 indicates method2, and so on).
Fig 3.
Example of NF breast: 50 years old woman, mammographic low-density (ACR B), left breast (DBT and ultrasonography BI-RADS 1).
Microwave images, normalized to unitary average of the intensity, are given in the top row for three different conductivity weightings (from left to right: 0.3 S/m, 0.4 S/m and 0.5 S/m, respectively). Microwave images are given here as 2D images in the azimuthal, i.e., coronal plane. Moreover, 1D intensity projection on X and Y is displayed in the inserts. X and Y are given in meters; intensity is in arbitrary units. The proposed rule-of-thumb classifies this breast as negative (the values of the microwave images’ selected features are provided in the S1B Table).
Fig 4.
Example of WF breast: Mammographic high-density (ACR D), left breast of 66 years old woman, with a group of microcalcifications.
Histopathology output is also given in the insert. Microwave images, normalized to unitary average of the intensity, are given in the top row for three different conductivity weightings (from left to right: 0.3 S/m, 0.4 S/m and 0.5 S/m, respectively). Microwave images are given here as 2D images in the azimuthal, i.e., coronal plane. Moreover, 1D intensity projection on X and Y is displayed in the inserts. X and Y are given in meters; intensity is in arbitrary units. All microwave images show a non-homogeneous behavior, with a main peak indicated by the red arrows. The proposed rule-of-thumb classifies this breast as positive (the values of the microwave images’ selected features are provided in the S1B Table).
Fig 5.
Example of WF breast: Mammographic heterogeneously dense (ACR C) right breast of 50 years old woman with a palpable nodule of 10 mm.
Histopathology output is also given in the insert. Microwave images, normalized to unitary average of the intensity, are given in the top row for three different conductivity weightings (from left to right: 0.3 S/m, 0.4 S/m and 0.5 S/m, respectively). Microwave images are given here as 2D images in the azimuthal, i.e., coronal plane. Moreover, 1D intensity projection on X and Y is displayed in the inserts. X and Y are given in meters; intensity is in arbitrary units. All microwave images show a non-homogeneous behavior, with a main peak indicated by the red arrows. The proposed rule-of-thumb classifies this breast as positive (the values of the microwave images’ selected features are provided in the S1B Table).
Fig 6.
Example of WF breast: Mammographic low density (ACR B) left breast of 70 years old woman with a mammographic parenchymal distortion of 8 mm confirmed by DBT in the lower outer quadrant.
Histopathology output is also given in the insert. Microwave images, normalized to unitary average of the intensity, are given in the top row for three different conductivity weightings (from left to right: 0.3 S/m, 0.4 S/m and 0.5 S/m, respectively). Microwave images are given here as 2D images in the azimuthal, i.e., coronal plane. Moreover, 1D intensity projection on X and Y is displayed in the inserts. X and Y are given in meters; intensity is in arbitrary units. All microwave images show a non-homogeneous behavior, with a main peak indicated by the red arrows. The proposed rule-of-thumb classifies this breast as positive (the values of the microwave images’ selected features are provided in the S1B Table).
Table 4.
MammoWave’s performance in breast lesions detection against reference standard.
Table 5.
Patients’ satisfaction related to MammoWave use in general.
Table 6.
Patients’ satisfaction related to MammoWave when compared to mammography.