Clinical trial · Interventional
Photo-Acoustic and Ultrasonographic Mammoscope
Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study
NCT07492589CI-TRIAL-00106487PAUSrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Breast Lesions | — | UNRESOLVED | — |
| Malignant Breast Tumours | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photo-Acoustic Mammoscope Imager 3+ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients
- description
- All patients included in this study will undergo measurements with the PAM3+ imager.
- interventionNames
- Device: Photo-Acoustic Mammoscope Imager 3+
Primary outcomes (1)
- measure
- PAM3+ performance
- timeFrame
- through study completion, an average of 1 year
- description
- 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 (12)
- measure
- Sensitivity
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.