[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652912":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":45,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Glioma patients enrolled in main study [18F]FMISO and [18F]FET PET\u002FMRI","EXPERIMENTAL","FET and FMISO PET\u002FMRI studies will be performed on either 1) same day or 2) separate days within 14 days of each other. Baseline imaging will occur within 21 days before surgery. Every effort will be made to perform these studies within 1 week of each other. FMISO-PET\u002FMRI will be administered first with a four-hour uptake time followed by a dynamic FET-PET\u002FMRI (\\\u003C90 min total scan time). For separate scans, FET-PET\u002FMRI will typically be performed first although the order can be switched if needed due to PET tracer production or scanner scheduling. Patients will fast for at least 4 hours prior to FET administration and will undergo dynamic scans. No fasting or other special preparation is required for FMISO studies and imaging will be acquired after a four-hour uptake time. Additional post-surgical FET-PET\u002FMRI scans at 1, 3 and 6 months post will follow the same steps as the separately acquired scans except no additional FMISO-PET\u002FMRI will be performed.",[13],"Drug: [18F]FMISO-PET with contrast-enhanced MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","[18F]FMISO-PET with contrast-enhanced MRI","Glioma patients enrolled in the main study (IRB 300007756) will complete 4 to 5 imaging visits. Visit 1 will take place prior to participants scheduled surgery. Visit 1 could be two seperate imaging visits between \\[18F\\]FMISO and \\[18F\\]FET, if needed. Participants will have three additional \\[18F\\]FET PET\u002FMRIs at 1 month, 3 months and 6 months post-surgery.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Anna Sorace, PhD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sebastian Eady","CONTACT","205-996-2636","smeady@uabmc.edu",[32],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"UAB","Birmingham","Alabama","35249","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-86.80249,33.52066,{"lat":43,"lon":42},{"type":24,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Anna G. Sorace","Associate Professor, Department of Radiology and Biomedical Engineering Division Director, Advanced Medical Imaging Research Division Director, Small Animal Imaliging Shared Facity","100652912","early-phase-1-multiparametric-metabolic-and-hypoxic-petmri-imaging-substudy-in-gliomas-100652912",false,"NCT07778979","Multiparametric Metabolic and Hypoxic PET\u002FMRI Imaging Substudy in Gliomas","Multiparametric Metabolic and Hypoxic PET\u002FMRI Imaging Substudy for Disease Assessment and Guidance of Catheters in Patients With Recurrent\u002FProgressive Malignant Gliomas Eligible for Catheter-delivered Therapies","Inclusion Criteria:\n\n1. Participants from IRB 300007756\n2. 18 years of age or older at the time of enrollment\n3. Able to undergo PET\u002FMRI without anesthesia or sedation. Minimal sedation with ananxiolytic such as alprazolam used routinely for SOC MRI is allowed.\n4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration of FET or FMISO.\n5. ECOG performance score of 2 or better\n6. Life expectancy greater than 12 weeks.\n\nExclusion Criteria:\n\n1. Any exclusions listed in IRB 300007756\n2. Pregnancy or breast feeding\n3. Inability to complete PET\u002FMRI scans.\n4. Significant renal dysfunction (estimated GFR \\\u003C 30 mL\u002Fmin)\n5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team\n6. Unable to undergo MRI\n7. Contraindication to gadolinium-based contrast","ALL","18 Years",{"count":58,"type":59},20,"ESTIMATED","INTERVENTIONAL",[62],"EARLY_PHASE1","This substudy will investigate a new imaging approach using positron emission tomography (PET) and two investigational drugs (\\[18F\\]FET and \\[18F\\]FMISO) to see if the imaging results will help with the placement of catheters for therapy delivery in 20 adult patients with malignant gliomas (MGs) who are participating in the UAB IRB approved main study, A Phase I\u002FII Study of Pembrolizumab and M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients with Recurrent\u002FProgressive and Newly Diagnosed Glioblastoma Multiforme, grade 3 or grade 4 astrocytoma, or Gliosarcoma (IRB 300007756 PI Markert). The PET and MR imaging results will be available to guide catheter placement within IRB 300007756 study-specific guidelines during Neurosurgery.",[65],"Glioma","NOT_YET_RECRUITING","2026-08-18",{"date":69,"type":70},"2026-08-21","ACTUAL",{"date":72,"type":59},"2026-09",{"date":74,"type":59},"2030-11",{"name":5,"class":6},1]