[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07467109":3,"trial-entities:NCT07467109":81,"trial-summary:NCT07467109":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":24,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":52,"locations":55,"central_contacts":73,"overall_officials":75,"references":77,"see_also_links":78},"NCT07467109","2025-0606","A Study to Evaluate the Safety and Efficacy of Intracranial Venous Blood Sampling for Liquid Biopsy in the Diagnosis of Brain Cancers","NOT_YET_RECRUITING","2029-05-01","2026-03","2026-03-19","2026-08-19","M.D. Anderson Cancer Center","OTHER",false,"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.","Primary Objectives The primary objective is to evaluate the safety and efficacy of intracranial venous sampling with or without BBB disruption with administration of intraarterial mannitol in participants with high grade gliomas.\n\n* The study will determine if intracranial venous blood sampling for liquid biopsy can facilitate accurate and precise molecular diagnosis in participants with high grade gliomas that is comparable to molecular diagnosis obtained during surgical brain biopsy.\n* The study will determine if intracranial venous blood sampling for liquid biopsy requires concomitant temporary blood brain barrier disruption with endovascular selective intraarterial infusion of mannitol for accurate and precise molecular diagnosis of high-grade gliomas.\n\nSecondary Objectives\n\n• The study will determine if intracranial venous blood sampling in participants with high grade gliomas results in higher yield of ctDNA and other biomarkers than peripheral venous blood sampling, and if this is further augmented by BBB disruption.",[18,19,20,21],"Intracranial Venous Blood","Brain Cancers","Liquid Biopsy","Evaluate the Safety",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","blood sampling","Done by IV",[35],"Intracranial Venous Blood Sampling With BBB Disruption",[37],{"measure":38,"description":39,"timeFrame":40},"safety and adverse events (AEs).","Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0","Through study completion; an average of 1 year",[],"ALL","18 Years",{"inclusion":45,"exclusion":46,"raw_text":51},[],[47,48,49,50],"Severe contrast allergy","Acute\u002Fchronic renal dysfunction with eGFR \\\u003C 45 ml\u002Fmin and Cr ≤ 1.5 mg\u002FdL 3. For participants undergoing surgery, refractory coagulopathy or thrombocytopenia which cannot be corrected defined as:","Platelets ≤100,000\u002FmcL","International Normalized Ratio ≤ 1.7 4. Subjects that have a known high risk in monitored anesthetic care or general anesthesia assessed by the treating physician. 5. 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. 6. Participants with clinical cerebral edema evidenced from altered mental status 7. Pregnant women due to risk of radiation exposure to the fetus, as determined by pregnancy urinalysis or serum analysis test during screening. 8. Subjects with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements at the physician's discretion.","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.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":57,"city":58,"state":59,"zip":60,"country":61,"contacts":62,"geoPoint":70},"MD Anderson Cancer Center","Houston","Texas","77030","United States",[63,68],{"name":64,"role":65,"phone":66,"email":67},"Christopher C Young, MD","CONTACT","713-745-4243","ccyoung1@mdanderson.org",{"name":64,"role":69},"PRINCIPAL_INVESTIGATOR",{"lat":71,"lon":72},29.76328,-95.36327,[74],{"name":64,"role":65,"phone":66,"email":67},[76],{"name":64,"affiliation":12,"role":69},[],[79],{"label":57,"url":80},"http:\u002F\u002Fmdanderson.org",{"nct_id":4,"conditions":82,"biomarkers":84},[83],"Glioma",[],{"nct_id":4,"found":86,"summary":87,"prompt_version":97},true,{"design":88,"status":89,"heading":90,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an observational study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.","completed","Study of Intracranial Venous Blood Sampling for Brain Cancer Diagnosis","This study is looking at a new way to diagnose brain cancers, specifically high-grade glioma (a type of aggressive brain tumor). Researchers want to see if taking blood samples directly from veins inside the brain (intracranial venous blood sampling) is safe and can provide the same detailed information about the tumor as a traditional surgical biopsy. This method is called a \"liquid biopsy.\" The study will also explore if temporarily opening the blood-brain barrier (a protective layer around the brain) using a medicine called mannitol helps get even more accurate information. You might be able to join if you are over 18 and have suspected or confirmed high-grade glioma and are already scheduled for a diagnostic cerebral angiogram. The main goal is to check for safety and any side effects.","Safety and adverse events will be measured through study completion, an average of 1 year.",130,"Participants will undergo blood sampling via IV. The study will last for an average of 1 year.","Not stated in the trial record.",[32],"v2"]