Benign Breast LesionsPhase 2PAUSNCT07492589
Photo-Acoustic and Ultrasonographic Mammoscope
A Phase 2 study testing Photo-Acoustic Mammoscope Imager 3+ in people with Benign Breast Lesions and Malignant Breast Tumours, run by Franciscus Gasthuis & Vlietland (Hospital) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Benign Breast Lesions, Malignant Breast Tumours
- What is being tested?
- Photo-Acoustic Mammoscope Imager 3+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Feb 2026to 1 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Franciscus Vlietland Ziekenhuis
Schiedam, South Holland, 3118 JH
Linda Riks, MD, 010 - 893 6010, l.riks@franciscus.nl
Linda Riks, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Photo-Acoustic Mammoscope Imager 3+
- Keywords
- Photo-acoustic imaging, PAUS, Fotoakoestiek
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo-Acoustic Mammoscope Imager 3+Device
Also called PAM3+
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | All patients included in this study will undergo measurements with the PAM3+ imager. Receives: Device: Photo-Acoustic Mammoscope Imager 3+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: through study completion, an average of 1 year
Secondary outcomes (12)
Sensitivity
To determine the sensitivity of the PAM3+ to detect breast lesions
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Adverse events
To investigate the rate of any adverse events (clavien-dindo)
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Breast LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Photo-acoustic Imager 3+ measurements will be performed on all included patients.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis & Vlietland (Hospital)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Riks, Franciscus Gasthuis & Vlietland (Hospital)
- Investigators
- T.M.A.L. Klem, MD, PhD, Principal investigator, Franciscus Gasthuis & Vlietland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492589
- Sponsor's protocol ID
- NL-010685
- Acronym
- PAUS
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study
- ClinicalTrials.gov ID
- NCT07492589
- Acronym / sponsor ID
- PAUS / NL-010685
- Conditions
- Benign Breast Lesions, Malignant Breast Tumours
- Keywords
- Photo-acoustic imaging, PAUS, Fotoakoestiek
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Franciscus Gasthuis & Vlietland (Hospital)University, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Photo-acoustic Imager 3+ measurements will be performed on all included patients.
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Photo-Acoustic Mammoscope Imager 3+All patients included in this study will undergo measurements with the PAM3+ imager. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo-Acoustic Mammoscope Imager 3+Also: PAM3+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. | Device | All patients |
Primary outcome
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).
12 secondary outcomes
Sensitivity
Time frame: through study completion, an average of 1 year
Positive predictive value
Time frame: through study completion, an average of 1 year
Specificity of the PAM3+
Time frame: through study completion, an average of 1 year
Differences in Performance
Time frame: through study completion, an average of 1 year
Accuracy
Time frame: through study completion, an average of 1 year
Mammary gland visibility
Time frame: through study completion, an average of 1 year
Agreement
Time frame: through study completion, an average of 1 year
Agreement
Time frame: through study completion, an average of 1 year
Patient Satisfaction
Time frame: Periprocedural
System usability score
Time frame: Periprocedural
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
Adverse events
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
T.M.A.L. Klem, MD, PhD principal investigator
Franciscus Gasthuis & Vlietland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Photo-Acoustic Mammoscope Imager 3+ in people with Benign Breast Lesions and Malignant Breast Tumours, run by Franciscus Gasthuis & Vlietland (Hospital) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linda Riks, MD (010 - 893 6010, l.riks@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAM3+ performance (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.