[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655861":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":27,"studyPopulation":27,"armGroups":34,"interventions":42,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":76,"collaborators":27,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":27,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":27,"enrollmentInfo":88,"targetDuration":27,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":27,"overallStatus":97,"whyStopped":27,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maximum Standardized Uptake Value in Abnormal Lung Parenchyma","Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET\u002FCT in areas of abnormal lung parenchyma suggestive of interstitial lung disease","Approximately 1 hour post injection",{"measure":14,"description":15,"timeFrame":12},"Maximum Standardized Uptake Value in Normal Lung Parenchyma","Maximum standardized uptake value (SUVmax) will be measured on 68Ga-FAPI-46 PET\u002FCT in normal lung parenchyma",[17,21,24],{"measure":18,"description":19,"timeFrame":20},"Specificity of 68Ga-FAPI-46 PET\u002FCT for Detection of Interstitial Lung Disease","Specificity will be calculated using diagnostic CT chest findings as the reference standard. Specificity is defined as the proportion of participants without CT evidence of interstitial lung disease that are identified as negative on 68Ga-FAPI-46 PET\u002FCT.","Baseline",{"measure":22,"description":23,"timeFrame":20},"Sensitivity of 68Ga-FAPI-46 PET\u002FCT for Detection of Interstitial Lung Disease","Sensitivity will be calculated using diagnostic CT chest findings consistent with interstitial lung disease as the reference standard. Sensitivity is defined as the proportion of participants with CT evidence of interstitial lung disease that are identified as positive on 68Ga-FAPI-46 PET\u002FCT",{"measure":25,"description":26,"timeFrame":20},"Accuracy of 68Ga-FAPI-46 PET\u002FCT for Detection of Interstitial Lung Disease","Accuracy will be calculated using diagnostic CT chest findings as the reference standard. Accuracy is defined as the proportion of true positive and true negative 68Ga-FAPI-46 PET\u002FCT findings among all evaluated findings.",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"⁶⁸Ga-FAPI-46 PET\u002FCT","EXPERIMENTAL","Subjects with interstitial lung disease will have a dose of 3 - 7 mCi (111 - 185MBq) of ⁶⁸Ga-FAPI-46 administered intravenously",[40,41],"Drug: ⁶⁸Ga-FAPI-46","Diagnostic Test: PET\u002FCT",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":27},"DRUG","⁶⁸Ga-FAPI-46","Subjects will have 68Ga-FAPI-46 intravenously administered",[36],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":27},"DIAGNOSTIC_TEST","PET\u002FCT","Subjects will complete a PET\u002FCT approximately 60-70 minutes after being given ⁶⁸Ga-FAPI-46",[36],[54],{"name":55,"affiliation":5,"role":56},"Livia F. Kruger, MD","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":27,"email":62},"Alicia Meek","CONTACT","507-422-9699","meek.alicia@mayo.edu",[64],{"facility":5,"status":27,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":27},"Rochester","Minnesota","55905","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-92.4699,44.02163,{"lat":74,"lon":73},{"type":56,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Livia Kruger","Principal Investigator","100655861","phase-1-a-phase-i-single-center-study-evaluating-68ga-fapi-46-petct-in-patients-with-interstitial-lung-disease-100655861",false,"NCT07817563","Study Evaluating 68GA-FAPI-46 PET\u002FCT in Patients With Interstitial Lung Disease","A Phase I Single Center Study Evaluating 68GA-FAPI-46 PET\u002FCT in Patients With Interstitial Lung Disease","Inclusion Criteria:\n\n* Clinical diagnosis of interstitial lung disease\n* Radiologic lung abnormalities on diagnostic CT chest\n* Anatomic imaging (clinical diagnostic CT chest) obtained within ≤ 180 days prior to the planned FAPI 46 imaging exam or within 14 days after the imaging exam.\n* Willingness and ability to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential\n* Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)\n* Need for emergent surgery that would be delayed by participation\n* Bacterial, viral, or fungal infections requiring systemic therapy\n* Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, or other conditions) that in the opinion of the investigator, physician of record and\u002For Sofie could compromise patient safety and\u002For protocol objectives.\n* No available chest CT radiological data\n* No clear diagnosis of ILD\n* Intolerability to perform the exam due to exuberant dyspnea or severely low pulmonary capacity.\n* Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \\[68Ga\\]FAPI-46 injection.\n* Known hypersensitivity to any excipients used in \\[68Ga\\]FAPI-46","ALL","18 Years",{"count":89,"type":90},10,"ESTIMATED","INTERVENTIONAL",[93],"PHASE1","The purpose of this research is to better understand the distribution of an investigational radioactive imaging agent called 68Ga-FAPI-46 in the lungs of people with interstitial lung disease (ILD) during a Positron Emission Tomography\u002FComputed Tomography (PET\u002FCT) scan.",[96],"Interstitial Lung Disease","NOT_YET_RECRUITING","2026-09-15",{"date":100,"type":101},"2026-09-18","ACTUAL",{"date":103,"type":90},"2026-10-16",{"date":105,"type":90},"2031-05",{"name":5,"class":6},1]