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Brief Title: Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery
Official Title: Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients With CNS Malignancy
Study ID: NCT03071913
Brief Summary: This pilot research trial studies blood brain barrier differences in patients with brain tumors undergoing surgery. Studying samples of tissue and blood from patients with brain tumors in the laboratory may help doctors to understand how well drugs get into different parts of a brain tumor. This may help them to determine which types of drugs may be best for treating brain tumors.
Detailed Description: PRIMARY OBJECTIVE: 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 OBJECTIVE: I. Establish correlation of BBB permeability with radiographic appearance for study patients. CORRELATIVE RESEARCH OBJECTIVE: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Name: Jann N. Sarkaria, M.D.
Affiliation: Mayo Clinic
Role: PRINCIPAL_INVESTIGATOR