Blood Brain Barrier Differences in Patients with Brain Tumors Undergoing Surgery

NCT03071913 | Completed DMC

• 4 other identifiers: MC1671U54CA210180NCI-2017-0029916-007782
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Neoplasm; Localized Brain Neoplasm; Metastatic Malignant Neoplasm in the Brain; Recurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken 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.

  At the time of surgery

Secondary Outcomes (1)

• Radiographic appearance at each tissue sample location

  At the time of surgery

Study Arms (1)

Observational (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; Other: Laboratory Biomarker Analysis

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of tissue and blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (biospecimen collection)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CNS malignancy

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, blood

MeSH Terms

Conditions

Central Nervous System Neoplasms; Brain Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Jann N. Sarkaria, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 7, 2017
• Study Start: September 20, 2017
• Primary Completion: January 11, 2023
• Study Completion: January 12, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-04

Locations

US (1)