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Photo-Acoustic and Ultrasonographic Mammoscope

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.

ClinicalTrials.gov IDNCT07492589

PhasePHASE2

Enrollment180

SponsorFranciscus Gasthuis & Vlietland (Hospital)

Age18 Years

SexFEMALE

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Conditions studied

Benign Breast Lesions, Malignant Breast Tumours

About this 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.

Interventions

Device: Photo-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.

Primary outcomes

PAM3+ performance (through study completion, an average of 1 year)

Eligibility information

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

Study locations

Franciscus Vlietland Ziekenhuis, Schiedam, South Holland 3118 JH Netherlands

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.