Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • Site IRB
    • Rochester, Minnesota: 16-007782
    • Scottsdale/Phoenix, Arizona: 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jann Sarkaria, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jann Sarkaria, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions