Photo-Acoustic and Ultrasonographic Mammoscope

Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study

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.

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