NCT07467109

A Study to Evaluate the Safety and Efficacy of Intracranial Venous Blood Sampling for Liquid Biopsy in the Diagnosis of Brain Cancers

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. * 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. * 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. Secondary Objectives • 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.

Conditions

• Intracranial Venous Blood
• Brain Cancers
• Liquid Biopsy
• Evaluate the Safety

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	blood sampling	Done by IV

Timeline

• Start date: 2026-08-19
• Primary completion: 2027-05-01
• Completion: 2029-05-01
• First posted: 2026-03-12
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States