[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659047":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":17,"armGroups":24,"interventions":31,"overallOfficials":17,"centralContacts":39,"locations":45,"responsibleParty":63,"collaborators":67,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":17,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":17,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Copenhagen University Hospital, Rigshospitalet","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Endpoint for the primary objective","The primary objective is to evaluate physicians' ability to accurately detect malignancy on \\[68Ga\\]FAPI-46 WB PET\u002FMRI compared with standard-of-care imaging modalities.\n\nThis will be assessed by calculating sensitivity, specificity, and positive and negative predictive values, using histopathology as the reference standard. If histopathology is unavailable, true positives may also be defined by consensus among the evaluating physicians, based on available imaging and the patient's electronic medical record during the 6-month follow up period.","From recruitment, at the time of each participant's initial evaluation, until 6 months after completion of participant recruitment. The trial duration, from the start of recruitment to end of participation, is expected to last 2.5 years.",[14],{"measure":15,"description":16,"timeFrame":12},"Endpoint of the secondary objective","Tissue samples collected as part of routine clinical care, will be used for immunohistochemical (IHC ) analysis of FAP expression. The histological presence of FAP in the tissue samples will be correlated with the standardized uptake value (SUV) of the corresponding lesion identified on \\[68Ga\\]FAPI-46 PET\u002FMRI. A standardardized questionnaire will be used to assess the experiences of the patient and\u002For parent(s).\n\nA final qualitative assessment of the technical feasibility of implementing this imaging modality in clinical practice will be conducted as part of the overall study evaluation. This assessment will consider any site-specific challenges associated with executing the experimental imaging protocol, the results of the image interpretation analyses, additional experiences gained during the study, and the time and costs associated with the protocol compared with current standard-of-care imaging modalities.",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE",[25],{"label":26,"type":27,"description":28,"interventionNames":29},"Experimental scans","ACTIVE_COMPARATOR","Each patient is administered a radioactive dose of \\[68Ga\\]FAPI-46 and undergoes a whole-body PET\u002FMRI followed by a whole-body PET\u002FCT on the same dose administration.",[30],"Drug: FAPI tracer",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","FAPI tracer","The patient is administered 2.0 MBq\u002Fkg of \\[68Ga\\]FAPI-46 radioactive tracer.",[26],[38],"IMP",[40],{"name":41,"role":42,"phone":43,"phoneExt":17,"email":44},"Sabrina Honoré d'Este, MD, Ph.D. student","CONTACT","0045 4535 4736","sabrina.honore.deste.01@regionh.dk",[46],{"facility":47,"status":17,"city":48,"state":17,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Dept. of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, DK-2100 CPH","Copenhagen","2100","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],12.56553,55.67594,{"lat":56,"lon":55},[59],{"name":60,"role":42,"phone":61,"phoneExt":17,"email":62},"Marie Øbro Fosbøl, MD, PhD, Specialist physician","0045 3545 3919","marie.oebro.fosboel@regionh.dk",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Marie Øbro Fosbøl","MD, PhD, certified specialist in Clinical Physiology and Nuclear Medicine",[68,71,73,75],{"name":69,"class":70},"Department of Clinical Physiology and Nuclear Medicine, Rigshospitalet, Denmark","UNKNOWN",{"name":72,"class":70},"Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark",{"name":74,"class":70},"Department of Pathology, Rigshospitalet, Denmark",{"name":76,"class":70},"Department of Clinical Medicine, University of Copenhagen, Denmark","100659047","phase-2-paediatric-sarcoma-hybrid-imaging--fapi---raising-the-diagnostic-standard-for-paediatric-sarcoma-patients-combining-novel-radiotracer-fapi-and-whole-body-petmri-100659047",false,"NCT07861217","Paediatric Sarcoma, Hybrid Imaging & FAPI - Raising the Diagnostic Standard for Paediatric Sarcoma Patients, Combining Novel Radiotracer FAPI and Whole-body PET\u002FMRI","Paediatric Sarcoma, Hybrid Imaging & FAPI - An Investigator-initiated, Non-inferiority, Single-group, Phase II Clinical Trial, Evaluating FAPI WB PET\u002FMRI at Primary Staging, Treatment Control and Relapse in Paediatric Sarcoma - The PsiFI Trial","PsiFI","Inclusion Criteria:\n\n* \\\u003C18 years old.\n* Referred to the Recruiting Department for evaluation of any type of sarcoma.\n* The patient and\u002For parent(s) must be able to read and understand the Participant Information Sheet (PIS) in Danish and\u002For English and provide innformed consent by signing the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Considered unable by the referring department to comply with the study imaging procedures without sedation.\n* Severe claustrophobia or any contraindication indentified through the MRI safety screening questionnaire.\n* History of an allergic reaction due to compounds with a chemical composition similar to that of \\[68Ga\\]FAPI-46.","ALL","17 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"PHASE2","The goal of this clinical trial is to evaluate \\[68Ga\\]FAPI-46 whole-body PET\u002FMRI as a diagnostic tool to improve tumour lesion examination at primary staging, during treatment control and at relapse in paediatric sarcoma patients.\n\nThe main questions the trial aim to answer are:\n\n* Is \\[68Ga\\]FAPI-46 whole-body PET\u002FMRI better at detecting malignancy in paediatric sarcoma patients compared to current standard of care imaging modalities?\n* Is the overall diagnostic performance of \\[68Ga\\]FAPI-46 whole-body PET\u002FMRI feasible to implement in clinical practice?\n\nThe intervention of \\[68Ga\\]FAPI-46 will be compared to current standard of care imaging modalities. All participants will receive their standard of care imaging protocol as rutinely scheduled, which includes:\n\n* A localized MRI scan of the tumour region and\n* An \\[18F\\]FDG whole-body PET\u002FCT scan\n\nIn addition to the standard of care imaging protocol, all patients will receive the following experimental scans:\n\n* An \\[18F\\]FDG whole-body PET\u002FMRI\n* A \\[68Ga\\]FAPI-46 whole-body PET\u002FMRI\n* A \\[68Ga\\]FAPI-46 whole-body PET\u002FCT\n\nAll patients and legal guardians will fill out questionnaires on their experiences. Patients may undergo the entire trial imaging procedures, including the standard of care imaging protocol and the experimental scans, a maximum of five times.",[95],"Sarcoma",[97,98,99,100],"pediatric sarcoma","WB PET\u002FMRI","FAPI","WB PET\u002FCT","NOT_YET_RECRUITING","2026-10-02",{"date":104,"type":105},"2026-10-06","ACTUAL",{"date":107,"type":89},"2026-12",{"date":109,"type":89},"2029-06",{"name":5,"class":6},1]