NCT07492589

Photo-Acoustic and Ultrasonographic Mammoscope

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Franciscus Gasthuis & Vlietland (Hospital) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Secondary, the diagnostic accuracy of the PAM3+ in the localization, and sizing breast lesions in relation to BI-RADS score, breast density, and conventional imaging is evaluated. This includes assessing usability, patient satisfaction, safety, and establishing the foundation for a PAM3+ lexicon.

Conditions

• Benign Breast Lesions
• Malignant Breast Tumours

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-31
• Completion: 2028-04-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: Netherlands