[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585831":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":33,"locations":40,"responsibleParty":77,"collaborators":81,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":38,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":38,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":120,"whyStopped":38,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Aminolevulinic acid hydrochloride","EXPERIMENTAL","Single arm study administering a single oral solution of aminolevulinic acid hydrochloride at a dose of 20 mg\u002Fkg body weight, 6-12 hours prior to brain surgery for resection of the tumor.",[13],"Drug: Aminolevulinic acid hydrochloride",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Pediatric patients diagnosed with a new or recurrent brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal will receive aminolevulinic acid hydrochloride prior to surgery for resection of the brain tumor.",[9],[20,21,22,23,24],"Gleolan®","ALA HCl","5-ALA","Aminolevulinic acid HCl","Aminolevulinic acid",[26,29],{"name":27,"affiliation":5,"role":28},"Constantinos G. Hadjipanayis, MD, PhD","STUDY_DIRECTOR",{"name":30,"affiliation":31,"role":32},"John Ruge, MD, FAANS","Midwest Children's Brain Tumor Center, Advocate Children's Hospital-Park Ridge","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Kristy Boggs, PhD","CONTACT","412-647-8952",null,"boggskd@upmc.edu",[41,60],{"facility":42,"status":38,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"MidWest Children's Brain Tumor Center, Advocate Children's Hospital Park Ridge","Chicago","Illinois","60068","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-87.65005,41.85003,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":38,"email":58},"John Ruge, MD","847-723-6611","john.ruge@aah.org",{"name":56,"role":32,"phone":38,"phoneExt":38,"email":38},{"facility":61,"status":38,"city":62,"state":63,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15224",{"type":49,"coordinates":66},[67,68],-79.99589,40.44062,{"lat":68,"lon":67},[71,75],{"name":72,"role":36,"phone":73,"phoneExt":38,"email":74},"Swetha Thambireddy, MPH","412-692-9960","swetha.thanbireddy@chp.edu",{"name":76,"role":32,"phone":38,"phoneExt":38,"email":38},"Cody Nesvick, MD",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Costas Hadjipanayis","L. Dade Lunsford Professor of Neurosurgery, Executive Vice Chairman",[82,85,88,90,92,94],{"name":83,"class":84},"NX Development Corp","INDUSTRY",{"name":86,"class":87},"Southeastern Brain Tumor Foundation","UNKNOWN",{"name":89,"class":87},"StacheStrong Foundation",{"name":91,"class":87},"Neuroscience Research Foundation",{"name":93,"class":6},"University of Pittsburgh Medical Center",{"name":95,"class":6},"Advocate Hospital System","100585831","phase-2-a-multicenter-study-to-assess-the-feasibility-of-5-aminolevulinic-acid-5-ala-in-pediatric-brain-tumor-patients-100585831",false,"NCT06907485","A Multicenter Study to Assess the Feasibility of 5-Aminolevulinic Acid (5-ALA) in Pediatric Brain Tumor Patients","A Multicenter Study to Assess the Feasibility of Gleolan (ALA \u002F Aminolevulinic Acid HCl) in Pediatric Brain Tumor Patients After Delayed Administration","Inclusion Criteria:\n\n1. Subjects included in this trial must have had an MRI documentation of \"a new or recurrent primary pediatric brain tumor\" for which resection is indicated and has been planned.\n2. The anticipated histology at resection will be \"newly diagnosed\" or \"recurrent\": pilocytic astrocytoma, pleomorphic xanthoastrocytoma (PXA), ganglioglioma, diffuse neuroepithelial tumor (DNET), astrocytoma, oligodendroglioma, ependymoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ependymoma, anaplastic ganglioglioma, anaplastic PXA, PNET, ATRT, or medulloblastoma.\n3. Male or Female Age 2-17 years and 182 days\n4. Subjects must have normal organ and marrow function as defined below:\n\n   Leukocytes \\>3,000\u002FmL Platelets \\>100,000\u002FmL Total bilirubin Below upper limit of normal (ULN) AST (SGOT)\u002FALT (SGPT)\u002F GGT \\\u003C2.5 X institutional age-specific ULN Creatinine Below ULN\n\n   OR\n\n   Creatinine Clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional age-specific normal as defined per institution.\n5. The effects of 5-ALA on the developing human fetus are unknown. A pregnancy test will be performed for all young women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a young woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n6. Ability for patient\u002Fpatient's guardian to understand and the willingness to sign a written informed consent document. In appropriate cases, assent of pediatric patients will be obtained. Translation will be provided as appropriate.\n7. Inclusion of Women and Minorities: Both males and females and members of all ethnic groups are eligible for this trial.\n\nExclusion Criteria:\n\n1. Patients who meet inclusion criteria but are unable to swallow 5-ALA solution.\n2. Patients with radiographic tumors of the brain stem as assessed by MRI.\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA. Patients should refrain from use of other potential phototoxic substances (e.g., tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 24 h.\n4. Personal or family history of porphyria.\n5. Uncontrolled concurrent illness including, but not limited to: ongoing or active infection, heart disease, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA breastfeeding should be discontinued if the mother is treated 5-ALA.\n6. Young women who are pregnant or become pregnant will be excluded from the trial as it is unknown if 5-ALA is teratogenic or has abortifacient effects. A pregnancy test will be performed on all young women who are s\u002Fp menstruation prior to entering study.\n7. Prior history of GI perforation, diverticulitis, and\u002For peptic ulcer disease.","ALL","2 Years","17 Years",{"count":107,"type":108},20,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","This clinical trial focuses on pediatric patients aged 2 up to 18 years of age with a new or recurrent pediatric brain tumor, suspected to be either a high-grade or low-grade glioma, and scheduled for surgical removal. 5-aminolevulinic acid (5-ALA) is FDA-approved for improving brain tumor visualization in adults during surgery through fluorescence, enabling more complete removal of the tumor. This study aims to evaluate the feasibility of administering 5-ALA to pediatric brain tumor patients and to assess the quality of tumor fluorescence during surgery in this patient population.\n\nFor the clinical trial, the patient will orally ingest 5-ALA 6 to 12 hours before brain surgery. All study participants will be provided standard medical care for removal of the brain tumor. All children enrolled in the study will be closely monitored prior to, during, and after surgery to ensure there are no reactions to the study drug. 5-ALA can make the patient more sensitive to sunlight and direct indoor lighting, referred to as photosensitivity, and can cause a sunburn-type reaction. It is for this reason that patients will be kept in subdued light conditions for 48 hours following surgery. Study participation starts once the patient is enrolled in the study until 6-month post-surgery.",[114],"Pediatric Brain Tumor",[116,20,117,118,119],"Aminolevulinic Acid (ALA)","Fluorescence-Guided Resection","Brain Tumor","Pediatric","NOT_YET_RECRUITING","2026-01-20",{"date":123,"type":124},"2026-01-21","ACTUAL",{"date":126,"type":108},"2026-08",{"date":128,"type":108},"2028-08",{"name":79,"class":6},2]