Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
PRIMARY OBJECTIVES:
- 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:
- Establish correlation of BBB permeability with radiographic appearance for study patients.
TERTIARY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ancillary-correlative (biospecimen collection) 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. |
Procedure: Biospecimen Collection
Undergo collection of tissue and blood samples
Other: Laboratory Biomarker Analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- BBB permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery [Blood samples taken approximately 20-30 minute intervals during surgery, Tissue sample taken one time during surgery]
The ratio of cefazolin and levetiracetam (or lorazepam) and gadolinium in blood taken every 20-30 minutes during surgery will be correlated with the tissue samples. Inter- and intra-subject variability over all patients will be estimated, within specific imaging features between patients, and within open biopsy specimens.
Secondary Outcome Measures
- Radiographic appearance at each tissue sample location [Tissue sample taken one time during surgery]
The results of the tissue samples will be compared with the radiographic appearance at each tissue sample location. This will be primarily descriptive in nature.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical and radiographic evidence suggesting CNS malignancy
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Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR previously untreated or treated brain metastasis
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Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester
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Able to have magnetic resonance imaging (MRI) imaging with gadolinium contrast (e.g. no cardiac pacemaker, defibrillator, renal failure)
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Provide written informed consent
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Willing to provide tissue and blood samples for research purposes
Exclusion Criteria:
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Vulnerable populations: pregnant women, prisoners, mentally handicapped
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Unable to undergo a biopsy of CNS lesion
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Documented drug allergy to cefazolin or levetiracetam, or other contraindication to use these drugs in the pre-operative setting (e.g., patient is already on another anti-seizure medication which precludes the clinical indication for pre-operative levetiracetam)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Jann Sarkaria, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MC1671
- NCI-2017-00299
- MC1671
- P30CA015083