Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Primary Purpose
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microdialysis
Sponsored by
About this trial
This is an interventional basic science trial for Anaplastic Astrocytoma
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years.
- ECOG performance status (PS) 0, 1 or 2.
- Clinical and radiographic evidence suggesting a diagnosis of a diffuse glioma, or a prior diagnosis of a diffuse glioma.
- Suspected primary brain neoplasm include astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma and anaplastic oligodendroglioma.
- Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor as part of routine clinical care.
- Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, MN).
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Vulnerable populations: pregnant women, prisoners or the mentally handicapped.
- Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness.
Sites / Locations
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Basic Science (microdialysis)
Arm Description
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.
Outcomes
Primary Outcome Measures
Incidence of adverse events
Will be assessed by evaluating the proportion of patients who: (2) develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microdialysate catheters. Attribution of neurologic deficit will typically be considered unlikely unless there is evidence of intra-operative intracranial hemorrhage that the surgeon deems to be attributable to use of the microdialysis catheter. Adverse events will be measured by Common Terminology Criteria for Adverse Events 5.0.
Targeted metabolomics
Metabolites within each region of tumor to brain-adjacent-to tumor within a patient compared. Metabolites from patients without central nervous system malignancies averaged across the epileptic foci group and descriptively compared to the areas from patients with gliomas.
Secondary Outcome Measures
Microdialysate D-2HG
Concentrations of D-2HG in microdialysate will be descriptively compared between patients with IDH mutated gliomas and those with IDH wildtype gliomas.
Non-enhancing (FLAIR)- region metabolites
Metabolites of non-glioma, edema-associated FLAIR region of metastatic tumors descriptively compared to those within non-enhancing FLAIR gliomas.
Necrotic core metabolites
The relative contribution of tumor cellularity versus blood-brain barrier disruption to metabolite production and loss determined by comparing metabolites within the necrotic tumor to those found within the enhancing tumor and brain -adjacent-to-tumor.
Percentage of samples in which stable isotope labeled L-methionine- 13C5, 15N detected
Stable isotope detection and tracing performed.
Full Information
NCT ID
NCT04047264
First Posted
July 29, 2019
Last Updated
May 24, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04047264
Brief Title
Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Official Title
Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial evaluates the use of microdialysis catheters during surgery to collect biomarkers, and studies the feasibility of intraoperative microdialysis during neurosurgery for central nervous system malignancies. A biomarker is a measurable indicator of the severity or presence of disease state. Information collected in this study may help doctors to develop new strategies to better diagnose, monitor, and treat brain tumors.
Detailed Description
PRIMARY OBJECTIVE:
I. Determine biomarkers of in situ gliomas across a diverse patient cohort using intra-operative microdialysis to sample extracellular metabolites.
SECONDARY OBJECTIVE:
I. Evaluate the yield and specificity of microdialysate D-2HG as a candidate tumor biomarker to differentiate between IDH-mutated and IDH-wildtype gliomas.
II. Identify biomarkers of tumor-associated processes including brain edema, brain infiltration with non-enhancing tumor, and tumor-associated hypoxia or necrosis.
III. Determine the contribution of blood-brain barrier disruption to metabolite abundance within enhancing gliomas.
IV. Determine the feasibility of detecting stable-isotope labeled metabolites in human microdialysate.
EXPLORATORY/CORRELATIVE OBJECTIVES:
I. Perform untargeted metabolomics of tumor microdialysate to elucidate extracellular biomarkers reflective of human central nervous system malignancy subtype, grade, and tumor region.
II. Banking of microdialysate specimens for future analyses.
OUTLINE:
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.
After completion of study, patients are followed up for 42 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Diffuse Astrocytoma, Diffuse Glioma, Glioblastoma, Metastatic Malignant Neoplasm in the Brain, Oligodendroglioma
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Basic Science (microdialysis)
Arm Type
Experimental
Arm Description
Patients undergo microdialysis over 30 minutes during standard of care biopsy or resection.
Intervention Type
Procedure
Intervention Name(s)
Microdialysis
Intervention Description
Undergo microdialysis
Primary Outcome Measure Information:
Title
Incidence of adverse events
Description
Will be assessed by evaluating the proportion of patients who: (2) develop persistent adverse events deemed related (possibly, probably, definitely) to the insertion or use of microdialysate catheters. Attribution of neurologic deficit will typically be considered unlikely unless there is evidence of intra-operative intracranial hemorrhage that the surgeon deems to be attributable to use of the microdialysis catheter. Adverse events will be measured by Common Terminology Criteria for Adverse Events 5.0.
Time Frame
Up to 42 days
Title
Targeted metabolomics
Description
Metabolites within each region of tumor to brain-adjacent-to tumor within a patient compared. Metabolites from patients without central nervous system malignancies averaged across the epileptic foci group and descriptively compared to the areas from patients with gliomas.
Time Frame
Up to 42 days
Secondary Outcome Measure Information:
Title
Microdialysate D-2HG
Description
Concentrations of D-2HG in microdialysate will be descriptively compared between patients with IDH mutated gliomas and those with IDH wildtype gliomas.
Time Frame
Up to 42 days
Title
Non-enhancing (FLAIR)- region metabolites
Description
Metabolites of non-glioma, edema-associated FLAIR region of metastatic tumors descriptively compared to those within non-enhancing FLAIR gliomas.
Time Frame
Up to 42 days
Title
Necrotic core metabolites
Description
The relative contribution of tumor cellularity versus blood-brain barrier disruption to metabolite production and loss determined by comparing metabolites within the necrotic tumor to those found within the enhancing tumor and brain -adjacent-to-tumor.
Time Frame
Up to 42 days
Title
Percentage of samples in which stable isotope labeled L-methionine- 13C5, 15N detected
Description
Stable isotope detection and tracing performed.
Time Frame
Up to 42 days
Other Pre-specified Outcome Measures:
Title
Microdialysate oncometabolites
Description
Will be assessed by untargeted metabolomic analyses will be tabulated and evaluated for hypothesis generation.
Time Frame
Up to 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Diagnosis of the following, based on clinical and radiographic evidence:
A diffuse glioma, or a prior diagnosis of a diffuse glioma. Diffuse gliomas include diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma and anaplastic oligodendroglioma
Metastatic brain tumor of any primary origin
Epileptic focus requiring surgical resection
Planned neurosurgical procedure for purposes of biopsy or resection of suspected or previously diagnosed brain tumor (primary or metastatic) or epileptic focus as part of routine clinical care
Willing to undergo neurosurgical resection or biopsy at Mayo Clinic (Rochester, Minnesota [MN])
Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
Vulnerable populations: pregnant women, prisoners or the mentally handicapped
Patients who are not appropriate candidates for surgery due to current or past medical history or uncontrolled concurrent illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence C Burns
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Terence C. Burns, M.D.
12. IPD Sharing Statement
Learn more about this trial
Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
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