Intracranial Venous Blood Sampling for Brain Tumor Liquid Biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the safety and potential diagnostic value of sampling intracranial venous blood, with or without temporary blood–brain barrier disruption using intraarterial mannitol, in adults with high-grade gliomas. The goal is to see if intracranial venous samples can provide molecular diagnoses comparable to surgical brain biopsy and whether BBB disruption enhances biomarker yield. Primary outcomes focus on safety and concordance with tissue-based molecular findings. Secondary aims compare biomarker yield between intracranial and peripheral blood samples and assess the impact of BBB disruption on detection. The study involves blood sampling during planned diagnostic or therapeutic brain procedures at MD Anderson Cancer Center.

Why it matters

Who can join: the full rules

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.

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Christopher C Young, MD — M.D. Anderson Cancer Center
• Study coordinator: Christopher C Young, MD
• Email: ccyoung1@mdanderson.org
• Phone: 713-745-4243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.