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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

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.

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.

Disqualifiers

Subjects with suspected glioma or other brain cancers who do not have a tissue diagnosis and no surgical biopsy or resection is anticipated.

Severe contrast allergy

Acute/chronic renal dysfunction with eGFR < 45 ml/min and Cr ≤ 1.5 mg/dL

Platelets ≤100,000/mcL

Trial population

MD Anderson Cancer Center

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • blood sampling

    Diagnostic test

    Done by IV

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Intracranial Venous Blood Sampling With BBB Disruption1 intervention

Trial outcomes

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

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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