Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery
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- STATUS
- Recruiting
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- End date
- Oct 15, 2022
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- participants needed
- 81
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- sponsor
- Mayo Clinic
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.
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 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.
Details
| Condition | Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm, Recurrent Brain Neoplasm |
|---|---|
| Treatment | laboratory biomarker analysis, biospecimen collection |
| Clinical Study Identifier | NCT03071913 |
| Sponsor | Mayo Clinic |
| Last Modified on | 31 January 2022 |
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