[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481940":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"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":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"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,"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":23,"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","100481940","early-phase-1-evaluation-of-18f-fluciclovine-positron-emission-tomography---magnetic-resonance-imaging-pet-mri-in-lgg-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":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"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.",[81,82,83,84,85],"Glioma","Low-grade Glioma","Low Grade Glioma of Brain","Glioma, Malignant","Glioma Intracranial",[81,82,83,84,85,9],"2026-04-24",{"date":89,"type":90},"2026-04-29","ACTUAL",{"date":92,"type":75},"2026-07-29",{"date":94,"type":75},"2027-09",{"name":5,"class":6},1]