NCT07467109

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
33mo left

Started Aug 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 19, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 9, 2026

Last Update Submit

March 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Diagnostic Test: blood sampling

Interventions

blood samplingDIAGNOSTIC_TEST

Done by IV

Intracranial Venous Blood Sampling With BBB Disruption

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MD Anderson Cancer Center

You may not qualify if:

  • Subjects with suspected glioma or other brain cancers who do not have a tissue diagnosis and no surgical biopsy or resection is anticipated.
  • 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
  • For participants undergoing surgery, refractory coagulopathy or thrombocytopenia which cannot be corrected defined as:
  • Platelets ≤100,000/mcL
  • International Normalized Ratio ≤ 1.7
  • Subjects that have a known high risk in monitored anesthetic care or general anesthesia assessed by the treating physician.
  • 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.
  • Participants with clinical cerebral edema evidenced from altered mental status
  • Pregnant women due to risk of radiation exposure to the fetus, as determined by pregnancy urinalysis or serum analysis test during screening.
  • Subjects with psychiatric illness/social situations that would limit compliance with study requirements at the physician's discretion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Christopher C Young, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher C Young, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start (Estimated)

August 19, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations