Photo-Acoustic and Ultrasonographic Mammoscope (PAUS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Breast Tumours; Benign Breast Lesions
• Intervention / Treatment: Device: Photo-Acoustic Mammoscope Imager 3+

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Linda Riks, MD; Phone Number: 010 - 893 6010; Email: l.riks@franciscus.nl

Study Locations

• Netherlands
  • South Holland
    • Schiedam, South Holland, Netherlands, 3118 JH
      • Recruiting
      • Franciscus Vlietland Ziekenhuis
      • Contact: Linda Riks, MD; Phone Number: 010 - 893 6010; Email: l.riks@franciscus.nl
      • Sub-Investigator: Linda Riks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All patients; All patients included in this study will undergo measurements with the PAM3+ imager.

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.; Other Names: PAM3+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAM3+ performance	To evaluate the performance of the PAM3+ system in breast imaging. Performance is defined as the negative predictive value in the detection of breast lesions (malignant and benign).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	To determine the sensitivity of the PAM3+ to detect breast lesions	through study completion, an average of 1 year
Positive predictive value	To determine the positive predictive value of the PAM3+ in the detection of breast lesions	through study completion, an average of 1 year
Specificity of the PAM3+	To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy)	through study completion, an average of 1 year
Differences in Performance	To identify differences in performance per Breast Imaging-Reporting and Data System (Bi-RADS) scores (2-5). It ranks 2 (benign) to 5 (malignant). A higher score means a higher chance of breast cancer.	through study completion, an average of 1 year
Accuracy	To investigate the accuracy of the PAM3+ device to assess lesion location and size with regard to breast density. The accuracy of the PAM3+ will be compared to conventional imaging techniques (mammography and ultrasound) Accuracy is defined as right size (<0.5cm difference is accepted) and location of the tumour.	through study completion, an average of 1 year
Mammary gland visibility	To determine whether the PAM3+ device can visualize the entire mammary gland, defined as imaging coverage extending from the subcutaneous tissue to the pectoral muscle, with the pectoral muscle visible in the acquired images.	through study completion, an average of 1 year
Agreement	To assess the agreement between tumor size measurements obtained with the PAM3+ device and those obtained using conventional imaging modalities (mammography and ultrasound) and histopathology, based on the maximum tumor diameter measured in millimeters.	through study completion, an average of 1 year
Agreement	To assess the agreement between tumor location identified with the PAM3+ device and tumor location determined by conventional imaging modalities and histopathology, defined by breast quadrant and clock-face position relative to the nipple. A difference of <0.5cm is accepted between all modalities.	through study completion, an average of 1 year
Patient Satisfaction	To assess patient satisfaction with the PAM3+ measurement using a patient satisfaction questionnaire administered immediately after the procedure, with responses recorded on a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied), where higher scores represent greater satisfaction.	Periprocedural
System usability score	To assess system usability of the PAM3+ device using the System Usability Scale (SUS) questionnaire administered immediately after the PAM3+ measurement. The SUS consists of 10 items rated on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Item scores are converted to a total SUS score ranging from 0 to 100, where higher scores indicate better perceived usability.	Periprocedural
Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging	This outcome measure evaluates the agreement between Breast Imaging Reporting and Data System (BI-RADS) categories (2-5) assigned by a radiologist using conventional imaging and the categories assigned by the PAM3+ technician using PAM3+ 3D imaging. A higher agreement outcome represents better agreement between both scores.	through study completion, an average of 1 year
Adverse events	To investigate the rate of any adverse events (clavien-dindo)	Periprocedural

Collaborators and Investigators

• Sponsor: Franciscus Gasthuis & Vlietland (Hospital)
• Investigators: Principal Investigator: T.M.A.L. Klem, MD, PhD, Franciscus Gasthuis & Vlietland

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Photo-acoustic imaging; PAUS; Fotoakoestiek
• Other Study ID Numbers: NL-010685

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No