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โ† Trials
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Photo-Acoustic and Ultrasonographic Mammoscope

RecruitingPhase 2Ages 18 Years - anyFemaleFranciscus Gasthuis & Vlietland (Hospital)
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Photo-Acoustic Mammoscope Imager 3+
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Where

1 site
Franciscus Vlietland Ziekenhuis
Schiedam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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