[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630816":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":53,"collaborators":32,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":32,"enrollmentInfo":66,"targetDuration":32,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Franciscus Gasthuis & Vlietland (Hospital)","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All patients","EXPERIMENTAL","All patients included in this study will undergo measurements with the PAM3+ imager.",[13],"Device: Photo-Acoustic Mammoscope Imager 3+",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Photo-Acoustic Mammoscope Imager 3+","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\u002Fbowl 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.",[9],[21],"PAM3+",[23],{"name":24,"affiliation":25,"role":26},"T.M.A.L. Klem, MD, PhD","Franciscus Gasthuis & Vlietland","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Linda Riks, MD","CONTACT","010 - 893 6010",null,"l.riks@franciscus.nl",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Franciscus Vlietland Ziekenhuis","RECRUITING","Schiedam","South Holland","3118 JH","Netherlands","NL",{"type":44,"coordinates":45},"Point",[46,47],4.38889,51.91917,{"lat":47,"lon":46},[50,51],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},{"name":29,"role":52,"phone":32,"phoneExt":32,"email":32},"SUB_INVESTIGATOR",{"type":26,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Linda Riks","MD","100630816","phase-2-photo-acoustic-and-ultrasonographic-mammoscope-100630816",false,"NCT07492589","Photo-Acoustic and Ultrasonographic Mammoscope","Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study","PAUS","Inclusion Criteria:\n\n1. Women\n2. Age \\> 18 years\n3. Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion\n4. Patients who are fully competent to give written informed consent\n5. Sufficient knowledge of the Dutch language to complete a questionnaire\n\nExclusion Criteria:\n\n1. Currently undergoing chemotherapy\n2. Discharge from the nipple(s)\n3. Breast ulcers or -wounds\n4. Currently suffering from mastitis\n5. Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)\n6. Irremovable piercings on\u002Fin the breast\n7. Pregnancy\n8. Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)\n9. 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\n10. A history of photosensitive disease (e.g. porphyria, lupus erythematosus)\n11. Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease\n12. Currently undergoing phototherapy\n13. Patients with a known allergy for PVC\n14. Patients that are not physically capable of climbing on the examination bed\n15. Patients that are not physically capable of laying on the examination bed during the measurements","FEMALE","18 Years",{"count":67,"type":68},180,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","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.",[74,75],"Benign Breast Lesions","Malignant Breast Tumours",[77,62,78],"Photo-acoustic imaging","Fotoakoestiek","2026-03-19",{"date":81,"type":82},"2026-03-25","ACTUAL",{"date":84,"type":82},"2026-02-01",{"date":86,"type":68},"2028-04-01",{"name":5,"class":6},1]