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Blood Brain Barrier Differences in Patients With Brain Tumors Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT03071913
Recruitment Status : Suspended (enrollment per protocol for the interim analysis)
First Posted : March 7, 2017
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment
Central Nervous System Neoplasm Metastatic Malignant Neoplasm in the Brain Primary Brain Neoplasm Recurrent Brain Neoplasm Procedure: Biospecimen Collection Other: Laboratory Biomarker Analysis

Detailed 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.


Study Type : Observational
Estimated Enrollment : 81 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients With CNS Malignancy
Actual Study Start Date : September 5, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Group/Cohort Intervention/treatment
Ancillary-correlative (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.
Procedure: Biospecimen Collection
Undergo collection of tissue and blood samples

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. BBB permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery [ Time Frame: Blood samples taken approximately 20-30 minute intervals during surgery, Tissue sample taken one time 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.


Secondary Outcome Measures :
  1. Radiographic appearance at each tissue sample location [ Time Frame: Tissue sample taken one time during surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071913


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jann Sarkaria Mayo Clinic

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT03071913     History of Changes
Other Study ID Numbers: MC1671
NCI-2017-00299 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1671 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Neoplasms, Second Primary
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases