[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576806":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":52,"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":79,"overallStatus":36,"whyStopped":32,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Aalborg University Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Suspected pleural mesothelioma","EXPERIMENTAL","Patients with suspected pleural mesotheliom undergo an additional study specific \\[68Ga\\]Ga-FAPI-46 PET\u002FCT at primary staging.",[13],"Drug: [68Ga]Ga-FAPI-46 PET\u002FCT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[68Ga]Ga-FAPI-46 PET\u002FCT","Patients with suspected pleural mesothelioma undergo FAPI PET\u002FCT in addition to conventional imaging at primary staging.\n\nThe subgroup of patients undergoing anticancer treatment will undergo an additional FAPI PET\u002FCT and FDG PET\u002FCT after completing 2-3 series of anticancer treatment.",[9],[21],"[68Ga]Gallium - Fibroblast Activation Protein Inhibitor-46 Positron Emission Tomography \u002F Computer Tomography",[23],{"name":24,"affiliation":25,"role":26},"Helle Zacho, MD, DMSc","Clinical Professor dept. of Nuclear Medicine, Aalborg University Hospital","STUDY_DIRECTOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Morten Bentestuen, MD","CONTACT","+45 97665500",null,"m.bentestuen@rn.dk",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Aalborg","Region North Jutland","9000","Denmark","DK",{"type":43,"coordinates":44},"Point",[45,46],9.9187,57.048,{"lat":46,"lon":45},[49],{"name":29,"role":30,"phone":50,"phoneExt":51,"email":33},"97665500","+45",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Morten Bentestuen","Principal Investigator","100576806","phase-2-the-diagnostic-accuracy-and-clinical-value-of-fapi-pet-in-pleural-mesothelioma-100576806",false,"NCT06790082","The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma","FAPI PET in Pleural Mesothelioma: The Diagnostic Accuracy and Clinical Value of FAPI PET at Diagnosis, Primary Staging, and the Feasibility of FAPI PET for Response Evaluation","FAPI-PM","Inclusion Criteria:\n\n* Patients with pleural lesions suspicious of pleural mesothelioma and referred to pleural biopsy.\n* Undergone\u002Fundergoing FDG PET\u002FCT as part of the diagnostic workup of a suspicious PM lesion.\n* Considered physically and mentally able to participate in the research project.\n* Understands the study subject information and able to consent to project participation.\n* 18-years or older\n\nExclusion Criteria:\n\n* Patients with an imminent need for surgery or in an emergency\n* Known concurrent other malignancy with active treatment within the last 1 year; non-melanoma skin cancer and cervical cancer in situ are exempt.\n* Pregnant or breastfeeding women.\n* Fertile women (women of childbearing potential) who could - theoretically - be pregnant (i.e., unknown pregnancy status).\n\nFertile women will be tested for pregnancy (by urine humane choriogonadotropin (HCG) or serum HCG) within 48h before FAPI PET\u002FCTs, both at primary staging and restaging. Study subjects can participate in the study if the pregnancy test is negative (i.e., not pregnant).\n\n* Subjects unable to undergo PET\u002FCT: e.g., weighing more than 180 kg (weight limit scanner), unable to fit within the imaging gantry, inability to remain still for the duration of the examination, or with known severe claustrophobia unresponsive to oral anxiolytics or severe fear of needles.\n* Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study.\n* History of allergic reactions \u002F hypersensitivity attributed to \\[18F\\]FDG or FAPI-tracers.","ALL","18 Years",{"count":67,"type":68},70,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","Seventy (N=70) patients with suspected pleural mesothelioma (PM) lesions referred to pleural biopsy will be recruited, and undergo an additional FAPI PET\u002FCT at primary staging.\n\nThe FAPI PET\u002FCT results will be compared to conventional imaging (including FDG PET\u002FCT). The diagnostic accuracy will be determined with histopathology as reference standard.\n\nFor patients undergoing anticancer treatment (chemotherapy, immunotherapy, other treatment), an additional FAPI PET\u002FCT and an additional FDG PET\u002FCT will be conducted after the study subjects have completed 2-3 series of anticancer treatment. The feasabilitiy of FAPI PET\u002FCT in response evaluation will be investigated.\n\nAll study specific analyzes will be blinded and will not influence the patient management \u002F treatment.",[74,75,76,77,78],"Pleural Mesothelioma","Pleural Diseases","Cancer","FAPI","Fibroblast Activation Protein Inhibitor",[77,80,81,74,82],"68Ga-FAPI-46","PET\u002FCT","FDG PET\u002FCT","2025-07-01",{"date":85,"type":86},"2025-07-03","ACTUAL",{"date":88,"type":86},"2025-01-29",{"date":90,"type":68},"2037-04-30",{"name":5,"class":6},1]