Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery

  • STATUS
    Recruiting
  • End date
    Oct 15, 2022
  • participants needed
    81
  • sponsor
    Mayo Clinic
Updated on 31 January 2022
cancer
renal failure
MRI
metastasis
brain metastases
brain tumor
nervous
primary brain tumors
cns malignancy

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.

Description

PRIMARY OBJECTIVES:

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 OBJECTIVES:

I. Establish correlation of BBB permeability with radiographic appearance for study patients.

TERTIARY OBJECTIVES:

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.

Details
Condition Central Nervous System Neoplasm, Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm, Recurrent Brain Neoplasm
Treatment laboratory biomarker analysis, biospecimen collection
Clinical Study IdentifierNCT03071913
SponsorMayo Clinic
Last Modified on31 January 2022

Eligibility

Yes No Not Sure

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 magnetic resonance imaging (MRI) imaging with gadolinium contrast (e.g. no cardiac pacemaker, defibrillator, renal failure)
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 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)
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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