[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100349464":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":65,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":45,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":45,"enrollmentInfo":80,"targetDuration":45,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":45,"overallStatus":50,"whyStopped":45,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Diagnostic (carbon C 13 pyruvate, MRSI)","EXPERIMENTAL","Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.",[13,14],"Drug: Hyperpolarized Carbon C 13 Pyruvate","Procedure: Magnetic Resonance Spectroscopic Imaging",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Hyperpolarized Carbon C 13 Pyruvate","Given IV",[9],[22,23],"Hyperpolarized 13C-Pyruvate","Hyperpolarized Pyruvate (13C)",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"PROCEDURE","Magnetic Resonance Spectroscopic Imaging","Undergo MRSI",[9],[30,31,32,33,34,35,36],"1H- Nuclear Magnetic Resonance Spectroscopic Imaging","1H-nuclear magnetic resonance spectroscopic imaging","Magnetic Resonance Spectroscopy","MRS","MRS Imaging","MRSI","Proton Magnetic Resonance Spectroscopic Imaging",[38],{"name":39,"affiliation":5,"role":40},"Dawid Schellingerhout","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":46},"CONTACT","713-794-5673",null,"dawid.schellingerhout@mdanderson.org",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-95.36327,29.76328,{"lat":60,"lon":59},[63,64],{"name":39,"role":43,"phone":44,"phoneExt":45,"email":45},{"name":39,"role":40,"phone":45,"phoneExt":45,"email":45},{"type":66,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[68],{"name":69,"class":70},"National Cancer Institute (NCI)","NIH","100349464","phase-1-hyperpolarized-carbon-c-13-pyruvate-in-diagnosing-glioma-in-patients-with-brain-tumors-100349464",false,"NCT03830151","Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors","Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation","Inclusion Criteria:\n\n* Written informed consent will be obtained from each participants including healthy volunteers.\n* Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.\n* All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial\n* Patient is \\>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.\n* Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.\n* Patient is able to understand and give consent to participation in the study.\n* Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.\n* Patient has a GFR \\> 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary.\n* Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.\n\nExclusion Criteria:\n\n* Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.\n* The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.\n* Pacemakers, electronic stimulation, metallic foreign bodies and devices and\u002For other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication\n* Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (\\> 6month) of non-CNS malignancy in remission, without evidence of current\u002F prior brain metastasis, will also not disqualify patient from participating.\n* History of cardiac arrhythmia","ALL","19 Years",{"count":81,"type":82},13,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.",[88],"Primary Brain Neoplasm","2026-01-12",{"date":91,"type":92},"2026-01-13","ACTUAL",{"date":94,"type":92},"2019-05-16",{"date":96,"type":82},"2028-12-31",{"name":5,"class":6},1]