Central Nervous System NeoplasmNCT03071913
Blood Brain Barrier Differences in Patients with Brain Tumors Undergoing Surgery
An observational study of Central Nervous System Neoplasm and Localized Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Neoplasm, Localized Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Biospecimen Collection and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2017to 12 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CNS malignancy
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients with CNS Malignancy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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 OBJECTIVE:
- Establish correlation of BBB permeability with radiographic appearance for study patients.
CORRELATIVE RESEARCH OBJECTIVE:
- 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.
- Conditions
- Central Nervous System Neoplasm, Localized Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Brain Neoplasm
- Being tested
- Biospecimen Collection, Laboratory Biomarker Analysis
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of tissue and blood samples
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery
Secondary outcomes (1)
Radiographic appearance at each tissue sample location
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.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start20 Sep 2017
- Primary completion11 Jan 2023
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jann N. Sarkaria, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071913
- Sponsor's protocol ID
- MC1671
- Other IDs
- U54CA210180, NCI-2017-00299, 16-007782
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2017
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Heterogeneity of the Blood Brain Barrier in Patients with CNS Malignancy
- ClinicalTrials.gov ID
- NCT03071913
- Acronym / sponsor ID
- MC1671
- Conditions
- Central Nervous System Neoplasm, Localized Brain Neoplasm, Metastatic Malignant Neoplasm in the Brain, Recurrent Brain Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 11 Jan 2023 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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 OBJECTIVE:
- Establish correlation of BBB permeability with radiographic appearance for study patients.
CORRELATIVE RESEARCH OBJECTIVE:
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen collection) | – | Procedure: Biospecimen Collection, Other: Laboratory Biomarker AnalysisAs 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CNS malignancy
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of tissue and blood samples | Procedure or surgery | Observational (biospecimen collection) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Observational (biospecimen collection) |
Primary outcome
Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery
Time frame: At the time of 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.
1 secondary outcome
Radiographic appearance at each tissue sample location
Time frame: At the time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jann N. Sarkaria, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Neoplasm and Localized Brain Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood brain barrier permeability as measured by the ratio of drugs in blood and tissue samples taken during surgery (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.