The aim of this study is to evaluate the negative predictive value of the Photo Acoustic Imager 3+ (PAM3+) in the detection of female breast lesions (malignant and benign)in an outpatient setting.
Secondary, the diagnostic accuracy of the PAM3+ in the localization, and sizing breast lesions in relation to BI-RADS score, breast density, and conventional imaging is evaluated. This includes assessing usability, patient satisfaction, safety, and establishing the foundation for a PAM3+ lexicon.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
180
Patients will lay in prone position on the PAM3+ with one breast at a time in the aperture of the machine. The breast is supported by a plastic cup that holds the breast in place. The aperture/bowl is filled with water. During the measurement, infrared light will be emitted onto the breast. Infrared light will be absorpted by red blood cells which results in contrast compared to its surroundings and it will cause minuscule movements in the surrounding water. These movements will be detected by the ultrasound detectors. The movements and the absorption together will create a 3D image of the breast.
Franciscus Vlietland Ziekenhuis
Schiedam, South Holland, Netherlands
RECRUITINGPAM3+ performance
To evaluate the performance of the PAM3+ system in breast imaging. Performance is defined as the negative predictive value in the detection of breast lesions (malignant and benign).
Time frame: through study completion, an average of 1 year
Sensitivity
To determine the sensitivity of the PAM3+ to detect breast lesions
Time frame: through study completion, an average of 1 year
Positive predictive value
To determine the positive predictive value of the PAM3+ in the detection of breast lesions
Time frame: through study completion, an average of 1 year
Specificity of the PAM3+
To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy)
Time frame: through study completion, an average of 1 year
Differences in Performance
To identify differences in performance per Breast Imaging-Reporting and Data System (Bi-RADS) scores (2-5). It ranks 2 (benign) to 5 (malignant). A higher score means a higher chance of breast cancer.
Time frame: through study completion, an average of 1 year
Accuracy
To investigate the accuracy of the PAM3+ device to assess lesion location and size with regard to breast density. The accuracy of the PAM3+ will be compared to conventional imaging techniques (mammography and ultrasound) Accuracy is defined as right size (\<0.5cm difference is accepted) and location of the tumour.
Time frame: through study completion, an average of 1 year
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Mammary gland visibility
To determine whether the PAM3+ device can visualize the entire mammary gland, defined as imaging coverage extending from the subcutaneous tissue to the pectoral muscle, with the pectoral muscle visible in the acquired images.
Time frame: through study completion, an average of 1 year
Agreement
To assess the agreement between tumor size measurements obtained with the PAM3+ device and those obtained using conventional imaging modalities (mammography and ultrasound) and histopathology, based on the maximum tumor diameter measured in millimeters.
Time frame: through study completion, an average of 1 year
Agreement
To assess the agreement between tumor location identified with the PAM3+ device and tumor location determined by conventional imaging modalities and histopathology, defined by breast quadrant and clock-face position relative to the nipple. A difference of \<0.5cm is accepted between all modalities.
Time frame: through study completion, an average of 1 year
Patient Satisfaction
To assess patient satisfaction with the PAM3+ measurement using a patient satisfaction questionnaire administered immediately after the procedure, with responses recorded on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), where higher scores represent greater satisfaction.
Time frame: Periprocedural
System usability score
To assess system usability of the PAM3+ device using the System Usability Scale (SUS) questionnaire administered immediately after the PAM3+ measurement. The SUS consists of 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Item scores are converted to a total SUS score ranging from 0 to 100, where higher scores indicate better perceived usability.
Time frame: Periprocedural
Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging
This outcome measure evaluates the agreement between Breast Imaging Reporting and Data System (BI-RADS) categories (2-5) assigned by a radiologist using conventional imaging and the categories assigned by the PAM3+ technician using PAM3+ 3D imaging. A higher agreement outcome represents better agreement between both scores.
Time frame: through study completion, an average of 1 year
Adverse events
To investigate the rate of any adverse events (clavien-dindo)
Time frame: Periprocedural