Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery

PRIMARY OBJECTIVES:

I. To define the heterogeneity of blood brain barrier (BBB) permeability by assessing drug
distribution in a population of patients with central nervous system (CNS) malignancy.

SECONDARY OBJECTIVES:

I. Establish correlation of BBB permeability with radiographic appearance for study patients.

TERTIARY OBJECTIVES:

I. To utilize tumor samples to investigate mechanisms for BBB heterogeneity.

OUTLINE:

As part of pre-operative standard of care, patients receive levetiracetam by injection and
cefazolin by injection. Patients are also offered lorazepam in the pre-operative area. At the
time of surgery, patients undergo approximately 2 tissue biopsies from 3-4 tumor locations.
This tissue is removed as part of the planned surgery, but it is also tested for research
purposes. During surgery, a blood sample is collected every 20-30 minutes beginning at the
time of skin incision until all of the research tumor samples have been removed. A minimum of
3 blood samples are collected up to a maximum of 12.

Inclusion Criteria:

- Clinical and radiographic evidence suggesting CNS malignancy

- Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR
previously untreated or treated brain metastasis

- Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester

- Able to have magnetic resonance imaging (MRI) imaging with gadolinium contrast (e.g.
no cardiac pacemaker, defibrillator, renal failure)

- Provide written informed consent

- Willing to provide tissue and blood samples for research purposes

Exclusion Criteria:

- Vulnerable populations: pregnant women, prisoners, mentally handicapped

- Unable to undergo a biopsy of CNS lesion

- Documented drug allergy to cefazolin or levetiracetam, or other contraindication to
use these drugs in the pre-operative setting (e.g., patient is already on another
anti-seizure medication which precludes the clinical indication for pre-operative
levetiracetam)