[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594601":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":21,"centralContacts":22,"locations":28,"responsibleParty":143,"collaborators":21,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":21,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":166,"whyStopped":21,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Medical University Innsbruck","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"GMB like or LGG like","There are 2 groups: group 1 (GBM-like) includes patients with high-grade gliomas and significant contrast enhancement on preoperative MRI. Group 2 (LGG-like) will include patients with suspected HGG and little to no contrast enhancement.",[12],"Device: KINEVO 900 S with BLUE 400",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","KINEVO 900 S with BLUE 400","The investigational device consists of a CE marked (MDR) surgical microscope KINEVO 900 S by Carl Zeiss Meditec AG, including the BLUE 400 fluorescence option. This microscope is equipped with an additional component (CALLAO), provided by the Carl Zeiss Meditec AG, that allows for extended, multispectral, image acquisition in the operating room. CALLAO consists of an optical setup with additional cameras, that can be mounted on the main system KINEVO 900 S, and a second light source for specific illumination during image acquisition with the CALLAO cameras.",[9],[20],"CALLAO",null,[23],{"name":24,"role":25,"phone":26,"phoneExt":21,"email":27},"Christian Freyschlag, Prof. Dr.","CONTACT","+43 (0)51250427463","christian.freyschlag@i-med.ac.at",[29,43,56,67,78,89,97,108,119,132],{"facility":30,"status":21,"city":31,"state":21,"zip":21,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Universitätsklinik für Neurochirurgie der Medizinischen Universität Innsbruck","Innsbruck","Austria","AT",{"type":35,"coordinates":36},"Point",[37,38],11.39454,47.26266,{"lat":38,"lon":37},[41],{"name":42,"role":25,"phone":21,"phoneExt":21,"email":21},"Christian Freyschlag, Prof. PD Dr.",{"facility":44,"status":21,"city":45,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Charité - Universitätsmedizin Berlin","Berlin","Germany","DE",{"type":35,"coordinates":49},[50,51],13.41053,52.52437,{"lat":51,"lon":50},[54],{"name":55,"role":25,"phone":21,"phoneExt":21,"email":21},"Anna-Gila Karbe, Dr.",{"facility":57,"status":21,"city":58,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Universitätsklinikum Freiburg - Klinik für Neurochirurgie im Neurozentrum","Freiburg im Breisgau",{"type":35,"coordinates":60},[61,62],7.85222,47.9959,{"lat":62,"lon":61},[65],{"name":66,"role":25,"phone":21,"phoneExt":21,"email":21},"Roland Rölz, PD Dr.",{"facility":68,"status":21,"city":69,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Universitätsklinikum Göttingen - Neurochirurgische Klinik","Göttingen",{"type":35,"coordinates":71},[72,73],9.93228,51.53443,{"lat":73,"lon":72},[76],{"name":77,"role":25,"phone":21,"phoneExt":21,"email":21},"Christoph Bettag, Dr.",{"facility":79,"status":21,"city":80,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Klinik und Poliklinik für Neurochirurgie, LMU Klinikum München","München",{"type":35,"coordinates":82},[83,84],13.31243,51.60698,{"lat":84,"lon":83},[87],{"name":88,"role":25,"phone":21,"phoneExt":21,"email":21},"Florian Ringel, Prof. Dr.",{"facility":90,"status":21,"city":80,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Klinikum rechts der Isar der Technischen Universität München",{"type":35,"coordinates":92},[83,84],{"lat":84,"lon":83},[95],{"name":96,"role":25,"phone":21,"phoneExt":21,"email":21},"Arthur Wagner, PD Dr.",{"facility":98,"status":21,"city":99,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Universitätsklinikum Münster - Klinik für Neurochirurgie","Münster",{"type":35,"coordinates":101},[102,103],7.62571,51.96236,{"lat":103,"lon":102},[106],{"name":107,"role":25,"phone":21,"phoneExt":21,"email":21},"Eric Suero Molina, PD Dr.",{"facility":109,"status":21,"city":110,"state":21,"zip":21,"country":46,"countryCode":47,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Universitätsklinikum Tübingen, Universitätsklinik für Neurochirurgie","Tübingen",{"type":35,"coordinates":112},[113,114],9.05222,48.52266,{"lat":114,"lon":113},[117],{"name":118,"role":25,"phone":21,"phoneExt":21,"email":21},"Constantin Röder, Prof. Dr.",{"facility":120,"status":21,"city":121,"state":21,"zip":21,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Inselspital Bern, Universitätsklinik für Neurochirurgie","Bern","Switzerland","CH",{"type":35,"coordinates":125},[126,127],7.44744,46.94809,{"lat":127,"lon":126},[130],{"name":131,"role":25,"phone":21,"phoneExt":21,"email":21},"Andreas Raabe, Prof. Dr.",{"facility":133,"status":21,"city":134,"state":21,"zip":21,"country":122,"countryCode":123,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Hôpitaux universitaires de Genève - NeuroCentre","Geneva",{"type":35,"coordinates":136},[137,138],6.14569,46.20222,{"lat":138,"lon":137},[141],{"name":142,"role":25,"phone":21,"phoneExt":21,"email":21},"Paul Constanthin, Dr.",{"type":144,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100594601","protoporphyrin-imaging-in-multispectral-evaluation-of-resections-100594601",false,"NCT07021573","Protoporphyrin Imaging in Multispectral Evaluation of Resections","PRIMER","Inclusion criteria:\n\n* Age Requirement: Patients must be 18 years of age or older.\n* Diagnosis: Patients with a preoperative diagnosis of a suspected high-grade glioma based demographics and MRI imaging.\n* MRI Findings: Patients must meet one of the following criteria:\n\n  * Group 1: Suspected high-grade glioma with contrast enhancement on MRI (GBM-like).\n  * Group 2: Suspected high-grade glioma without contrast enhancement on MRI (LGG-like).\n* Surgical Resection: Patients scheduled to undergo surgical resection of the tumor as part of standard treatment.\n* 5-ALA Administration: Patients who will receive 5-aminolevulinic acid (5-ALA) for fluorescence guidance during surgery.\n* Post-op MRI: Patients who are able to undergo pre- and postoperative MRI (standard of care at the center).\n* Informed Consent: Patients who are able to understand and provide written informed consent prior to enrollment in the study.\n* Eligibility for Multispectral Imaging: Patients whose surgical procedures allow for the use of multispectral imaging technology for tumor visualization.\n* Performance Status: Patients with a Karnofsky Performance Status (KPS) of 60 or greater, indicating that they are capable of at least limited self-care.\n* No Prior Treatment: Patients who have not received prior treatment for the current brain tumor, including surgery, radiotherapy, or chemotherapy.\n\nExclusion criteria:\n\n* Patients with a known allergy or contraindication to 5-aminolevulinic acid (5-ALA) or its components.\n* Use of all other fluorescent markers.\n* Patients with a history of porphyria or other disorders related to 5-ALA metabolism.\n* Patients with recurrent gliomas or those who have received prior treatment for their current brain tumor, including surgery, radiotherapy, or chemotherapy.\n* Pregnant or breastfeeding patients, due to potential risks associated with 5-ALA administration.\n* Patients with severe comorbidities or other medical conditions that, in the investigator's opinion, would pose an unacceptable risk or compromise the safety of participation in the study.\n* Patients with a Karnofsky Performance Status (KPS) below 60, indicating an inability to perform minimal self-care.\n* Patients with a history of severe hepatic or renal impairment that may impact the metabolism of 5-ALA.\n* Patients unable to undergo MRI imaging for any reason (e.g., presence of non-MRI-compatible implants).\n* Patients unable to provide written informed consent due to cognitive, language, or other barriers.\n* Patients with tumors located in regions where fluorescence imaging is not technically feasible or where the use of multispectral imaging could interfere with the standard surgical approach.\n* Pregnancy","ALL","18 Years","99 Years",{"count":156,"type":157},80,"ESTIMATED","INTERVENTIONAL",[160],"NA","Observational non-interventional investigation to evaluate the potential of multispectral imaging in improving tumor visualization.",[163],"Glioma",[165],"Suspected high-grade gliomas","NOT_YET_RECRUITING","2025-09-08",{"date":169,"type":170},"2025-09-09","ACTUAL",{"date":172,"type":157},"2025-09-30",{"date":174,"type":157},"2026-05-01",{"name":5,"class":6},10]