Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Experimental | All patients included in this study will undergo measurements with the PAM3+ imager. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photo-Acoustic Mammoscope Imager 3+ | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PAM3+ 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). | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | To determine the sensitivity of the PAM3+ to detect breast lesions | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linda Riks, MD | Contact | 010 - 893 6010 | l.riks@franciscus.nl |
| Name | Affiliation | Role |
|---|---|---|
| T.M.A.L. Klem, MD, PhD | Franciscus Gasthuis & Vlietland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscus Vlietland Ziekenhuis | Recruiting | Schiedam | South Holland | 3118 JH | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Photo-acoustic Imager 3+ measurements will be performed on all included patients.
Not provided
Not provided
The PAM3+ outcomes will be assessed by an analyst that is completely masked from all other diagnostic imaging results. After receiving output from the analyst, full results will be (pseudo)anonymously shared with the analyst.
Not provided
|
|
| 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) | 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. | 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. | through study completion, an average of 1 year |
| 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. | 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. | 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. | 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. | 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. | 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. | through study completion, an average of 1 year |
| Adverse events | To investigate the rate of any adverse events (clavien-dindo) | Periprocedural |