Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Central Nervous System Neoplasm
- Metastatic Malignant Neoplasm in the Brain
- Primary Brain Neoplasm
- Recurrent Brain Neoplasm
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 st...
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.
Tracking Information
- NCT #
- NCT03071913
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Jann Sarkaria Mayo Clinic