Clinical trial · Observational
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
NCT03071913CI-TRIAL-00081128completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Neoplasm | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Localized Brain Neoplasm | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Brain | — | UNRESOLVED | — |
| Recurrent Brain Neoplasm | Brain Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (biospecimen collection)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Laboratory Biomarker Analysis
Primary outcomes (1)
- measure
- Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery
- timeFrame
- At the time of surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>= 18 years * Clinical and radiographic evidence suggesting CNS malignancy * Suspected newly diagnosed, local, or intracranial recurrence of primary brain tumor OR previously untreated or treated brain metastasis * Willing to undergo a neurosurgical resection of CNS lesion at Mayo Clinic Rochester * Able to have magnetic resonance imaging (MRI) imaging with gadolinium contrast (e.g. no cardiac pacemaker, defibrillator, renal failure) * Females of childbearing potential must have a negative pregnancy test done =\< 14 days prior to registration * Provide written informed consent * Willing to provide tissue and blood samples for research purposes * Patients having a study-specific surgical planning MRI only: Creatinine (estimated glomerular filtration rate \[eGFR\] \>= 30) (obtained =\< 30 days prior to registration) Exclusion Criteria: * Vulnerable populations: pregnant women, prisoners, mentally handicapped * Unable to undergo a biopsy of CNS lesion * 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) * Patients who are unable to swallow tablets if study drug is administered by mouth * Patients who are at risk for impaired absorption of oral medication if study drug is administered by mouth; Note: This includes but not limited to, refractory vomiting, gastric resection/bypass, and duodenal/jejunal resection * Pregnant or nursing women; Note: Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy; there is also a potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with these drugs, so breastfeeding should be discontinued for the duration of the study
References
Publications (0)
Data not yet available
No reference posted for this study.