Photo-Acoustic and Ultrasonographic Mammoscope

Recruiting now · Phase 2

Conditions studied: Benign Breast Lesions, Malignant Breast Tumours

In brief

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.

Key facts

Study ID

NCT07492589

Run by

Franciscus Gasthuis & Vlietland (Hospital)

People needed

180

Starts

2026-02-01

Expected to finish

2028-04-01

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Franciscus Vlietland Ziekenhuis — Schiedam, South Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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