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Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047264
Recruitment Status : Recruiting
First Posted : August 6, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Terry Burns, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 29, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
Primary: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability} [ Time Frame: 2 years ]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability}
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Official Title  ICMJE A Pilot Trial to Evaluate the Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Brief Summary Microdialysis permits sampling of molecules from the extracellular fluid, and has been utilized for studies of pharmacokinetics, and recovery of biomarkers. Gliomas remain incurable--in part due to limited access to human tumor biology in available preclinical models. This study utilizes a variable rate pump (M dialysis 107) and a high molecular weight cut-off catheter (71 high cut-off brain microdialysis catheter) to recover an expanded range of potential biomarkers from the diseased human central nervous system in the context of surgery for brain tumors. This study is performed under an investigational device exemption for use of these clinical grade devices that are not otherwise FDA approved for general use. The study will evaluate the safety of these devices and the feasibility of their use to collect analytes with sizes up to 100kDA. Analysis will be performed to evaluate the yield of oncometabolites and other potential biomarkers in appropriate regions of tumor and brain adjacent to tumor. Data obtained from analysis of samples collected will facilitate the design of future observational and interventional studies for central nervous system malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Microdialysis
Intervention  ICMJE Device: Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter
Each microdialysis catheter will be connected to a M dialysis 107 pump, with flow rates between 0.5 and 1.5 µL per minute. Prior to tumor removal, catheters will be placed within appropriate regions of tumor core or adjacent tissue with assistance of neuronavigation. Any awake or asleep neurophysiological mapping and/or additional localization-guided tissue sampling procedures will be performed while microdialysis is in progress, including cortical or subcortical language or motor mapping. Microdialysis will end when the region being sampled is removed as part of the planned tumor resection. The tissue region sampled by each catheter will be harvested separately for correlative analyses.
Study Arms  ICMJE Experimental: Mutant or WT tumor
Patients with suspected or biopsy-proven IDH-mutant tumor. Patients with suspected or biopsy-proven IDH-WT tumor
Intervention: Device: Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew D Hoplin 507-422-2121 hopolin.matthew@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04047264
Other Study ID Numbers  ICMJE 19-004694
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Terry Burns, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mayo Clinic
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP