Benign Breast Lesions, Malignant Breast Tumours
Conditions
Keywords
Photo-acoustic imaging, PAUS, Fotoakoestiek
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPhoto-Acoustic Mammoscope Imager 3+
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.
Sponsors
Franciscus Gasthuis & Vlietland (Hospital)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
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.
Intervention model description
Photo-acoustic Imager 3+ measurements will be performed on all included patients.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Women 2. Age \> 18 years 3. Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion 4. Patients who are fully competent to give written informed consent 5. Sufficient knowledge of the Dutch language to complete a questionnaire
Exclusion criteria
1. Currently undergoing chemotherapy 2. Discharge from the nipple(s) 3. Breast ulcers or -wounds 4. Currently suffering from mastitis 5. Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO) 6. Irremovable piercings on/in the breast 7. Pregnancy 8. Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup) 9. Currently using medication that increases photo-toxicity of the skin or skin care products that increase photosensitivity (e.g. certain antibiotics: tetracyclines or quinolones, certain antidiuretics 10. A history of photosensitive disease (e.g. porphyria, lupus erythematosus) 11. Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease 12. Currently undergoing phototherapy 13. Patients with a known allergy for PVC 14. Patients that are not physically capable of climbing on the examination bed 15. Patients that are not physically capable of laying on the examination bed during the measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PAM3+ performance | through study completion, an average of 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | through study completion, an average of 1 year | To determine the sensitivity of the PAM3+ to detect breast lesions |
| Positive predictive value | through study completion, an average of 1 year | To determine the positive predictive value of the PAM3+ in the detection of breast lesions |
| Specificity of the PAM3+ | through study completion, an average of 1 year | To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy) |
| Differences in Performance | through study completion, an average of 1 year | 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. |
| Accuracy | through study completion, an average of 1 year | 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. |
| Mammary gland visibility | through study completion, an average of 1 year | 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. |
| Agreement | through study completion, an average of 1 year | 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. |
| Patient Satisfaction | Periprocedural | 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. |
| System usability score | Periprocedural | 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. |
| Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging | through study completion, an average of 1 year | 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. |
| Adverse events | Periprocedural | To investigate the rate of any adverse events (clavien-dindo) |
Countries
Netherlands
Contacts
CONTACTLinda Riks, MD
PRINCIPAL_INVESTIGATORT.M.A.L. Klem, MD, PhD
Franciscus Gasthuis & Vlietland
Outcome results
None listed