Trials / Completed
CompletedNCT03071913
Blood Brain Barrier Differences in Patients with Brain Tumors Undergoing Surgery
Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients with CNS Malignancy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 54 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Central Nervous System Neoplasm
- Localized Brain Neoplasm
- Metastatic Malignant Neoplasm in the Brain
- Recurrent Brain Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo collection of tissue and blood samples |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
Timeline
- Start date
- 2017-09-20
- Primary completion
- 2023-01-11
- Completion
- 2023-01-12
- First posted
- 2017-03-07
- Last updated
- 2024-09-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03071913. Inclusion in this directory is not an endorsement.