[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481748":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":56,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":38,"whyStopped":31,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-Fluciclovine PET-MRI in pediatric HGG or DMG participants","EXPERIMENTAL","Single intravenous administration of 18F fluciclovine for PET-MRI Scan",[13],"Drug: 18F-Fluciclovine PET-MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","18F-Fluciclovine PET-MRI","18F-Fluciclovine will be injected via IV prior to Positron emission tomography (PET)-Magnetic resonance imaging (MRI)",[9],[21],"Axumin",[23],{"name":24,"affiliation":5,"role":25},"Mariam Aboian, MD,PhD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Mariam Aboian, MD, PhD","CONTACT","215-510-7661",null,"aboianm@chop.edu",{"name":34,"role":29,"phone":31,"phoneExt":31,"email":35},"Nazanin Maleki, MD","malekin@chop.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-75.16362,39.95238,{"lat":48,"lon":47},[51,52,53],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":31,"phoneExt":31,"email":35},{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":55,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[57,60],{"name":58,"class":59},"Blue Earth Diagnostics","INDUSTRY",{"name":61,"class":62},"Dragon Master Foundation","UNKNOWN","100481748","early-phase-1-18f-fluciclovine-pet-mri-in-high-grade-glioma-100481748",false,"NCT05553041","18F-Fluciclovine PET-MRI in High-grade Glioma","Evaluation of 18F-Fluciclovine PET-MRI to Differentiate Tumor Progression From Post-treatment Changes in Pediatric High-grade Glioma (HGG)","Inclusion Criteria\n\n* 1\\. Histopathology-proven HGG (WHO grade III-IV) or DMG (WHO grade IV) or, in the case of DMG of the pons, imaging that is characteristic of Diffuse intrinsic pontine gliomas (DIPG) (diffusely infiltrating \\>=2\u002F3 of the pons).\n* 2\\. Measurable disease, measuring at least 1x1 cm.\n* 3\\. Life expectancy of greater than 8 weeks.\n* 4\\. Age \\> 1 years but \\< 21 years of age at enrollment.\n\nFor those without planned surgery:\n\n* 1\\. Participants with clinical and\u002For radiographic suspicion of True progression (TP) or Pseudoprogression (PsP) during radiation but yet to have the initial post-radiation MRI scan.\n\nor\n\n* 2\\. Participants with suspicion for TP or PsP on first post-radiation MRI\n\nFor those with planned surgery:\n\n* 1\\. Clinical or radiographic suspicion of tumor progression with plan to undergo surgery or biopsy.\n\nExclusion Criteria:\n\n* 1\\. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n* 2\\. Pregnant or breastfeeding participants.\n* 3\\. Participant who would require sedation or anesthesia for imaging beyond standard of care (SOC).\n* 4\\. Participants who weigh less than 8 kg.\n* 5\\. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n* 6\\. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n\n  7\\. Participants with primary tumors of the spinal cord.","ALL","1 Year","21 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas. Investigators seek to determine if this imaging will help doctors tell the difference between tumor growth (progression) and other tumor changes that can occur after treatment.",[81,82,83,84,85],"Glioma","High Grade Glioma","Glioma, Malignant","Glioma Intracranial","Diffuse Glioma",[81,82,83,84,85,87],"18F fluciclovine","2025-12-03",{"date":90,"type":91},"2025-12-04","ACTUAL",{"date":93,"type":91},"2024-08-07",{"date":95,"type":75},"2027-12",{"name":5,"class":6},1]