Photo-Acoustic and Ultrasonographic Mammoscope
Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study
Franciscus Gasthuis & Vlietland (Hospital)
180 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Women
- Age \> 18 years
- Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
- Patients who are fully competent to give written informed consent
- Sufficient knowledge of the Dutch language to complete a questionnaire
Exclusion Criteria15
- Currently undergoing chemotherapy
- Discharge from the nipple(s)
- Breast ulcers or -wounds
- Currently suffering from mastitis
- Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
- Irremovable piercings on/in the breast
- Pregnancy
- Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)
- 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
- A history of photosensitive disease (e.g. porphyria, lupus erythematosus)
- Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease
- Currently undergoing phototherapy
- Patients with a known allergy for PVC
- Patients that are not physically capable of climbing on the examination bed
- Patients that are not physically capable of laying on the examination bed during the measurements
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Interventions
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.
Locations(1)
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NCT07492589