NCT07492589

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
20mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Apr 2028

Study Start

First participant enrolled

February 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

March 11, 2026

Last Update Submit

March 19, 2026

Conditions

Benign Breast LesionsMalignant Breast Tumours

Keywords

Photo-acoustic imagingPAUSFotoakoestiek

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Sensitivity

    through study completion, an average of 1 year

  • Positive predictive value

    through study completion, an average of 1 year

  • Specificity of the PAM3+

    through study completion, an average of 1 year

  • Differences in Performance

    through study completion, an average of 1 year

  • Accuracy

    through study completion, an average of 1 year

  • +7 more secondary outcomes

Study Arms (1)

All patients

EXPERIMENTAL

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

Device: Photo-Acoustic Mammoscope Imager 3+

Interventions

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.

Also known as: PAM3+
All patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Franciscus Vlietland Ziekenhuis

Schiedam, South Holland, 3118 JH, Netherlands

RECRUITING

Study Officials

  • T.M.A.L. Klem, MD, PhD

    Franciscus Gasthuis & Vlietland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Riks, MD

CONTACT

010 - 893 6010l.riks@franciscus.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Masking Details
The PAM3+ outcomes will be assessed by an analyst that is completely masked from all other diagnostic imaging results. After receiving output from the analyst, full results will be (pseudo)anonymously shared with the analyst.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Photo-acoustic Imager 3+ measurements will be performed on all included patients.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 25, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

NL(1)