[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558232":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":18,"responsibleParty":38,"collaborators":40,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":18,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":18,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":18},{"fullName":5,"class":6},"A.O.U. Città della Salute e della Scienza","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photodynamic diagnosis using Hexvix","EXPERIMENTAL","Transurethral resection of the bladder (TURB) is performed using photodynamic diagnosis (PDD) which involves the of use the study drug (Hexvix) to allow for better visualisation and subsequent resection",[13],"Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix",{"label":15,"type":16,"description":17,"interventionNames":18},"White light","NO_INTERVENTION","Transurethral resection of the bladder (TURB) is performed using the standard white light procedure",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Transurethral resection of the bladder performed with PDD tecnique and Hexvix","For the execution of PDD cystoscopy in blue light, it is necessary to use the study drug (Hexvix) which, after intravesical instillation, causes an accumulation of porphyrins in the lesions of the bladder wall at the intracellular level. The intracellular porphyrins are photoactive fluorescent compounds that emit red light when excited with blue light. Consequently, the preneoplastic and neoplastic lesions will emit a red luminescence against a blue background, allowing for better visualisation and subsequent resection.",[9],[26],{"name":27,"affiliation":28,"role":29},"Francesco Soria","AOU Città della Salute e della Scienza","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","0116336594","francesco.soria@unito.it",{"name":36,"role":32,"phone":18,"phoneExt":18,"email":37},"Lisa Giacometti","lisa.giacometti@cpo.it",{"type":29,"investigatorFullName":27,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Principal Investigator",[41],{"name":42,"class":43},"Photocure","INDUSTRY","100558232","phase-4-the-impact-of-pdd-during-turb-for-nmibc-100558232",false,"NCT06548438","The Impact of PDD During TURB for NMIBC","The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial","TUR_BLUE","Inclusion Criteria:\n\n* Voluntarily signed informed consent per Good Clinical Practice and national regulations\n* Age ≥ 18 years\n* Patient planned for TURB for \\>1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.\n\nExclusion Criteria:\n\n* Patients with history of recurrent NMIBC\n* Patients with visible incomplete resection during primary TURB\n* Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC","ALL","18 Years",{"count":55,"type":56},300,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg\u002F50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour.\n\nPatients will be randomised to:\n\n* Transurethral resection of the bladder (TURB) with a standard white light tecnique\n* TURB with the PDD tecnique using the study drug Hexvix",[62],"Bladder Cancer",[64,65,66,67],"TURB","re-TURB","photodynamic diagnosis-PDD","Hexvix","NOT_YET_RECRUITING","2024-08-07",{"date":71,"type":72},"2024-08-12","ACTUAL",{"date":74,"type":56},"2024-09-01",{"date":76,"type":56},"2027-09-01",{"name":5,"class":6}]