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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA210180 | U.S. NIH Grant/Contract | View source | |
| NCI-2017-00299 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 16-007782 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of tissue and blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken 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. | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic appearance at each tissue sample location | 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. | At the time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CNS malignancy
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| Name | Affiliation | Role |
|---|---|---|
| Jann N. Sarkaria, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Tissue, blood
| Laboratory Biomarker Analysis | Other | Correlative studies |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |