Recruitment

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