[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481940":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":55,"id":62,"slug":31,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":31,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":38,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"18F-Fluciclovine","EXPERIMENTAL","18F-Fluciclovine PET-MRI",[13],"Drug: 18F-Fluciclovine",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","18F-Fluciclovine will be injected via IV prior to PET-MRI imaging",[9],[20],"Axumin",[22],{"name":23,"affiliation":24,"role":25},"Mariam Aboian, MD,PhD","The Children s Hospital of Philadelphia","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":24,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Philadelphia","Pennsylvania","19104","United States",{"type":44,"coordinates":45},"Point",[46,47],-75.16362,39.95238,{"lat":47,"lon":46},[50,51,52],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":31,"phoneExt":31,"email":35},{"name":23,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":54,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[56,59],{"name":57,"class":58},"Blue Earth Diagnostics","INDUSTRY",{"name":60,"class":61},"Dragon Master Foundation","UNKNOWN","100481940",false,"NCT05555550","Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG","Evaluation of 18F-Fluciclovine PET-MRI as a Biomarker of Response in Pediatric and Young Adult Patients With Low Grade Gliomas (LGG)","Inclusion Criteria\n\n1. LGG including the brainstem and supratentorial only (WHO grade I-II), confirmed by biopsy unless in NF1 participants with classic appearance.\n2. Participants must have evaluable disease (1x1 cm tumor on MRI)\n3. Scheduled to receive systemic therapy for LGG\n4. Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n5. Age: Participants must be ≥ 1 years but ≤21 years of age at registration\n6. Being on a treatment regimen does not exclude a subject from enrollment.\n\nExclusion Criteria\n\n1. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n2. Pregnant participants\n3. Participants who weigh less than 8 kg.\n4. Participants who cannot avoid contact with a pregnant woman or infant for at least 12 hours following injection.\n5. Participants with a history of abnormal kidney function or creatinine \\>= CTCAE v5.0 grade 2 at time of study registration.\n6. Participants with primary tumors of the spinal cord.","ALL","1 Year","21 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.",[79,80,81,82,83],"Glioma","Low-grade Glioma","Low Grade Glioma of Brain","Glioma, Malignant","Glioma Intracranial",[79,80,81,82,83,9],"2026-04-24",{"date":87,"type":88},"2026-04-29","ACTUAL",{"date":90,"type":73},"2026-07-29",{"date":92,"type":73},"2027-09",{"name":5,"class":6},1]