Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07467109

Conditions

Intracranial Venous Blood

Brain Cancers

Liquid Biopsy

Evaluate the Safety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood sampling

Study Details

Brief 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.

Conditions

Intracranial Venous Blood

Brain Cancers

Liquid Biopsy

Evaluate the Safety

Study ID

NCT07467109

Start date

Apr 13, 2026

Status verified date

Mar, 2026

Completion date

May 1, 2029

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Eligibility Criteria

1. 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.
2. 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.
3. 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 (+/- 1 week) of the planned liquid biopsy.
4. 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/resection is desirable but not necessary for inclusion in the study.

• Ability to understand and the willingness to sign an informed consent document.
5. 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.
6. 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.
7. 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.
8. Karnofsky Performance Scale ≥ 60%
9. Participants must have adequate organ and marrow function as defined below:

hemoglobin ≥ 7mg/dL absolute neutrophil count ≥ 1,000/mcL platelets ≥ 100,000/mcL International Normalized Ratio ≤ 1.7 AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ 1.5mg/dL

Exclusion Criteria

1. Subjects with suspected glioma or other brain cancers who do not have a tissue diagnosis and no surgical biopsy or resection is anticipated.
2. Subjects in whom diagnostic cerebral angiogram is contra-indicated defined as:

  • Severe contrast allergy
  • Acute/chronic renal dysfunction with eGFR < 45 ml/min and Cr ≤ 1.5 mg/dL
3. For participants undergoing surgery, refractory coagulopathy or thrombocytopenia which cannot be corrected defined as:

  • Platelets ≤100,000/mcL
  • 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/or 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/social situations that would limit compliance with study requirements at the physician's discretion.

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Intracranial Venous Blood Sampling With BBB Disruption

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.

Interventions

blood sampling

Done by IV

Primary outcome measure

  • safety and adverse events (AEs). [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Christopher C Young, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Sep 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-09-09.