RecruitingPhase 2

Photo-Acoustic and Ultrasonographic Mammoscope

Netherlands180 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

PAM3+ performance

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT07492589

SponsorFranciscus Gasthuis & Vlietland (Hospital)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Linda Riks, MD

010 - 893 6010 l.riks@franciscus.nl

View on ClinicalTrials.gov More Benign Breast Lesions trials