Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-007782
NCT ID: NCT03071913
Sponsor Protocol Number: MC1671
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Age ≥ 18 years old.
- 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 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
- For patients having a study-specific surgical planning MRI only. The following lab values 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, levetiracetam, or other study drugs, 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 AEs in nursing infants secondary to treatment of the mother with these drugs, so breastfeeding should be discontinued for the duration of the study.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Jann Sarkaria, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available