[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628858":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":66,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracranial Venous Blood Sampling With BBB Disruption",null,"Comparisons will be made between the peripheral, intracranial venous blood and intracranial arterial blood, before and after BBB disruption to evaluate the amount of ctDNA and the degree of concordance between molecular markers for tumor diagnosis.",[13],"Diagnostic Test: blood sampling",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","blood sampling","Done by IV",[9],[21],{"name":22,"affiliation":5,"role":23},"Christopher C Young, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","713-745-4243","ccyoung1@mdanderson.org",[30],{"facility":31,"status":10,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"MD Anderson Cancer Center","Houston","Texas","77030","United States","US",{"type":38,"coordinates":39},"Point",[40,41],-95.36327,29.76328,{"lat":41,"lon":40},[44,45],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100628858","a-study-to-evaluate-the-safety-and-efficacy-of-intracranial-venous-blood-sampling-for-liquid-biopsy-in-the-diagnosis-of-brain-cancers-100628858",false,"NCT07467109","A Study to Evaluate the Safety and Efficacy of Intracranial Venous Blood Sampling for Liquid Biopsy in the Diagnosis of Brain Cancers","Eligibility Criteria\n\n1. Subjects over the age of 18 with suspected or confirmed, recently diagnosed, previously treated or recurrent high-grade glioma (WHO grade III and IV) in whom a diagnostic cerebral Angiogram is indicated as standard of care may be approached for participation in this study.\n2. Subjects are eligible if review of relevant intracranial cerebrovascular anatomy by cross sectional imaging such as CTA head and MRI brain, is deemed suitable for endovascular intracranial venous sampling.\n3. For subjects with suspected or recently diagnosed glioma, subjects are eligible if they have or are scheduled to undergo surgical biopsy or surgical resection of the tumor within 4 weeks (+\u002F- 1 week) of the planned liquid biopsy.\n4. For subjects with previously treated or recurrent glioma in whom tissue diagnosis and molecular profiling had been previously performed on surgical specimens at any time in the past, a planned surgical biopsy\u002Fresection is desirable but not necessary for inclusion in the study.\n\n   • Ability to understand and the willingness to sign an informed consent document.\n5. For participants with known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 6 months, if indicated.\n6. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 6 months.\n7. Participants with a known history of human immunodeficiency virus (HIV on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n8. Karnofsky Performance Scale ≥ 60%\n9. Participants must have adequate organ and marrow function as defined below:\n\nhemoglobin ≥ 7mg\u002FdL absolute neutrophil count ≥ 1,000\u002FmcL platelets ≥ 100,000\u002FmcL International Normalized Ratio ≤ 1.7 AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ 1.5mg\u002FdL\n\nExclusion Criteria\n\n1. Subjects with suspected glioma or other brain cancers who do not have a tissue diagnosis and no surgical biopsy or resection is anticipated.\n2. Subjects in whom diagnostic cerebral angiogram is contra-indicated defined as:\n\n   * Severe contrast allergy\n   * Acute\u002Fchronic renal dysfunction with eGFR \\\u003C 45 ml\u002Fmin and Cr ≤ 1.5 mg\u002FdL\n3. For participants undergoing surgery, refractory coagulopathy or thrombocytopenia which cannot be corrected defined as:\n\n   * Platelets ≤100,000\u002FmcL\n   * International Normalized Ratio ≤ 1.7\n4. Subjects that have a known high risk in monitored anesthetic care or general anesthesia assessed by the treating physician.\n5. Anatomic considerations: based on cross-sectional imaging such as CT angiogram of the head and neck, the anatomy for arterial and venous vascular access is deemed unsuitable for endovascular access such as high-grade carotid artery stenosis, absent or occluded internal jugular veins, sigmoid sinuses and\u002For transverse sinuses.\n6. Participants with clinical cerebral edema evidenced from altered mental status\n7. Pregnant women due to risk of radiation exposure to the fetus, as determined by pregnancy urinalysis or serum analysis test during screening.\n8. Subjects with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements at the physician's discretion.","ALL","18 Years",{"count":57,"type":58},20,"ESTIMATED","OBSERVATIONAL","To learn if drawing blood directly from veins inside the brain is safe and can effectively provide the same kind of detailed information about high-grade glioma as traditional surgical biopsy.",[62,63,64,65],"Intracranial Venous Blood","Brain Cancers","Liquid Biopsy","Evaluate the Safety","NOT_YET_RECRUITING","2026-03-18",{"date":69,"type":70},"2026-03-19","ACTUAL",{"date":72,"type":58},"2026-08-19",{"date":74,"type":58},"2029-05-01",{"name":5,"class":6},1]