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NCT Number: NCT07492589

Photo-Acoustic and Ultrasonographic Mammoscope

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.

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Key information

Conditions

Benign Breast Lesions Malignant Breast Tumours

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Franciscus Vlietland Ziekenhuis

Schiedam, South Holland, 3118 JH, Netherlands

Location status: Recruiting

Location contact

Linda Riks, MD

CONTACT

[email protected]

010 - 893 6010

Linda Riks, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women
  • Age > 18 years
  • Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
  • Patients who are fully competent to give written informed consent
  • Sufficient knowledge of the Dutch language to complete a questionnaire

Exclusion criteria

  • Currently undergoing chemotherapy
  • Discharge from the nipple(s)
  • Breast ulcers or -wounds
  • Currently suffering from mastitis
  • Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
  • Irremovable piercings on/in the breast
  • Pregnancy
  • Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)
  • 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
  • A history of photosensitive disease (e.g. porphyria, lupus erythematosus)
  • Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease
  • Currently undergoing phototherapy
  • Patients with a known allergy for PVC
  • Patients that are not physically capable of climbing on the examination bed
  • Patients that are not physically capable of laying on the examination bed during the measurements

Treatment and study plan

Photo-Acoustic Mammoscope Imager 3+

Device

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+

Primary outcomes

  1. PAM3+ performance

    Time frame: through study completion, an average of 1 year

    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).

Secondary outcomes

  1. Sensitivity

    Time frame: through study completion, an average of 1 year

    To determine the sensitivity of the PAM3+ to detect breast lesions

  2. Positive predictive value

    Time frame: through study completion, an average of 1 year

    To determine the positive predictive value of the PAM3+ in the detection of breast lesions

  3. Specificity of the PAM3+

    Time frame: through study completion, an average of 1 year

    To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy)

  4. Differences in Performance

    Time frame: through study completion, an average of 1 year

    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.

  5. Accuracy

    Time frame: through study completion, an average of 1 year

    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.

  6. Mammary gland visibility

    Time frame: through study completion, an average of 1 year

    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.

  7. Agreement

    Time frame: through study completion, an average of 1 year

    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.

  8. Agreement

    Time frame: through study completion, an average of 1 year

    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.

  9. Patient Satisfaction

    Time frame: Periprocedural

    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.

  10. System usability score

    Time frame: Periprocedural

    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.

  11. Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging

    Time frame: through study completion, an average of 1 year

    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.

  12. Adverse events

    Time frame: Periprocedural

    To investigate the rate of any adverse events (clavien-dindo)

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Riks, MD

CONTACT

[email protected]

010 - 893 6010

Sponsors and collaborators

Lead sponsor

Franciscus Gasthuis & Vlietland (Hospital)

Other

Registry information

Official study title

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

Acronym: PAUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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