Photo-acoustic and ultrasound breast imaging with the PAM3+

Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study

This project tests whether the Photo Acoustic Imager 3+ (PAM3+) can reliably rule out benign and malignant breast lesions in women referred to an outpatient breast clinic.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Franciscus Gasthuis & Vlietland (Hospital) (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Schiedam, South Holland)
• Trial ID: NCT07492589 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women over 18 referred to the outpatient breast clinic for evaluation of a possible breast lesion who can give informed consent and complete Dutch questionnaires are ideal candidates.

Not a fit: Women currently receiving chemotherapy, pregnant women, those with active mastitis, open breast wounds or nipple discharge, carriers of resistant bacteria, or those using photosensitizing medications or with incompatible piercings are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, PAM3+ could reduce unnecessary biopsies and speed up diagnosis by more accurately ruling out malignancy in some women.

How similar studies have performed: Photo-acoustic breast imaging is an emerging technique with promising pilot data but limited large-scale clinical validation, so this approach remains relatively novel.

Eligibility criteria

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 this trial is running

Schiedam, South Holland

• 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

Conditions Benign Breast Lesions; Malignant Breast Tumours; Photo-acoustic imaging; PAUS; Fotoakoestiek