Photo-acoustic and ultrasound breast imaging with the PAM3+

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial uses the Photo Acoustic Imager 3+ (PAM3+) alongside routine breast imaging in an outpatient clinic to measure how well it identifies breast lesions. The primary goal is to determine the device's negative predictive value for distinguishing benign from malignant lesions. Secondary analyses compare PAM3+'s ability to localize and size lesions against BI-RADS scores, breast density, and conventional imaging, and will collect data on usability, patient satisfaction, and safety. The study will also develop an initial PAM3+ imaging lexicon to help standardize interpretation.

Why it matters

Who can join: the full rules

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

Where it's running

• Franciscus Vlietland Ziekenhuis
  Schiedam, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: T.M.A.L. Klem, MD, PhD — Franciscus Gasthuis & Vlietland
• Study coordinator: Linda Riks, MD
• Email: l.riks@franciscus.nl
• Phone: 010 - 893 6010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.