Intracranial Venous BloodNCT07467109
A Study to Evaluate the Safety and Efficacy of Intracranial Venous Blood Sampling for Liquid Biopsy in the Diagnosis of Brain Cancers
An observational study of Intracranial Venous Blood and Brain Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Venous Blood, Brain Cancers, Liquid Biopsy
- What is being tested?
- blood sampling
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2026to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
None listed.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Christopher C Young, MD, 713-745-4243, ccyoung1@mdanderson.org
Christopher C Young, MD
About this study
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.
Read the 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.
- Being tested
- blood sampling
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingDiagnostic test
Done by IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start13 Apr 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Venous BloodStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher C Young, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467109
- Sponsor's protocol ID
- 2025-0606
- Other IDs
- NCI-2026-01761
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Intracranial Venous Blood Sampling for Liquid Biopsy in the Diagnosis of Brain Cancers
- ClinicalTrials.gov ID
- NCT07467109
- Acronym / sponsor ID
- 2025-0606
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial Venous Blood Sampling With BBB Disruption | – | Diagnostic Test: blood samplingComparisons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- 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:
- For participants undergoing surgery, refractory coagulopathy or thrombocytopenia which cannot be corrected defined as:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingDone by IV | Diagnostic test | Intracranial Venous Blood Sampling With BBB Disruption |
Primary outcome
safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Assessment of Venous Drainage in Idiopathic Intracranial Hypertension
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher C Young, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Venous Blood and Brain Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher C Young, MD (713-745-4243, ccyoung1@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.