[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456785":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":10,"maxAge":10,"enrollmentInfo":69,"targetDuration":10,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients eligible for [68Ga]-PSMA-617-PET",null,"All cancer patients referred by their physician and fulfilling the eligibility criteria across Canada can be recruited to the primary site of the study. Patients will be injected intravenously with a \\[68Ga\\]-PSMA-617 dose calculated depending on the characteristics of the PET tomograph and patient weight (maximum 370 MBq). 60-90 minutes following injection, patients will be imaged in a PET\u002FCT scanner. Images will be analyzed by a trained nuclear medicine physician. Safety profile, eventual adverse effects, false positives, false negatives and any abnormal biodistribution of the radiotracer will be monitored and analysed.",[13],"Diagnostic Test: [68Ga]-PSMA-617",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","[68Ga]-PSMA-617","The intervention consists of an intravenous injection of the radiopharmaceutical \\[68Ga\\]-PSMA-617 and a physiological saline flush, followed 60-90 minutes later by a PET\u002FCT image acquisition.",[9],[21],"PSMA-PET",[23],{"name":24,"affiliation":25,"role":26},"Éric E Turcotte, MD","Université de Sherbrooke, Centre de Recherche du CHUS","PRINCIPAL_INVESTIGATOR",[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Stéphanie Dubreuil","CONTACT","819-346-1110","16617","Stephanie.Dubreuil2@usherbrooke.ca",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Michel Paquette, PhD","11982","michel.paquette@usherbrooke.ca",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"CHUS","RECRUITING","Sherbrooke","Quebec","J1H5N4","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-71.89908,45.40008,{"lat":51,"lon":50},[54,57],{"name":24,"role":30,"phone":31,"phoneExt":55,"email":56},"11887","Eric.e.turcotte@usherbrooke.ca",{"name":29,"role":30,"phone":31,"phoneExt":32,"email":58},"Stephanie.dubreuil2@usherbrooke.ca",{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100456785","68ga-psma-617-petct-for-psma-expressing-tumor-a-pragmatic-study-100456785",false,"NCT05228106","68Ga-PSMA-617 PET\u002FCT for PSMA-expressing Tumor: a Pragmatic Study","Pragmatic Study on the Use of 68Ga-PSMA-617 PET\u002FCT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA.","Inclusion Criteria:\n\n1. Clinical requisition for a 68Ga-PSMA-617 PET\u002FCT signed by a referring doctor;\n2. Patients with suspected, proven or prior tumor expressing PSMA;\n3. Informed consent by patient.\n\nExclusion Criteria:\n\n1. Patient refusal to participate;\n2. Prior severe anaphylactic reaction to 68Ga-PSMA-617 .","ALL",{"count":70,"type":71},1000,"ESTIMATED","OBSERVATIONAL","This project aims to monitor the innocuity\u002Fsafety profile of cyclotron-produced \\[68Ga\\]-PSMA-617 PET imaging in PSMA-expressing cancers. It is a single-site, pragmatic, non-randomized and open-label study, with no control group. Although prostate cancers constitute the usual recommended population for this PET modality, recent evidences suggest that most solid tumors express substantial amount of PSMA in their neovasculature. As such, all cancers (excluding non-solid cancers) will be eligible for \\[68Ga\\]-PSMA-617 PET imaging in this trial, for as long as their tumors express PSMA.\n\nThis study also aims to instigate the use of \\[68Ga\\]-PSMA-617 in the routine standard-of-care for detection and follow-up of eligible cancers. FInally, this project seeks to gather information about the impact on patient management this novel PET modality will have over the current standard-of-care.",[75],"Solid Cancers",[17,77,78,79],"PET imaging","Pragmatic study","PSMA-expressing cancers","2024-02-05",{"date":82,"type":83},"2024-02-07","ACTUAL",{"date":85,"type":83},"2022-01-21",{"date":87,"type":71},"2027-01-31",{"name":5,"class":6},1]