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RECRUITING
NCT07492589
PHASE2

Photo-Acoustic and Ultrasonographic Mammoscope

Sponsor: Franciscus Gasthuis & Vlietland (Hospital)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-02-01

Completion Date

2028-04-01

Last Updated

2026-03-25

Healthy Volunteers

No

Interventions

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.

Locations (1)

Franciscus Vlietland Ziekenhuis

Schiedam, South Holland, Netherlands