Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Microdialysis Device: Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Trial to Evaluate the Feasibility of Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: Mutant or WT tumor
Patients with suspected or biopsy-proven IDH-mutant tumor. Patients with suspected or biopsy-proven IDH-WT tumor
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.




Primary Outcome Measures :
  1. Primary: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability} [ Time Frame: 2 years ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability}



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT04047264


Contacts
Layout table for location contacts
Contact: Matthew D Hoplin 507-422-2121 hopolin.matthew@mayo.edu

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Matthew D Hoplin    507-422-2121    hoplin.matthew@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Additional Information:
Layout table for additonal information
Responsible Party: Terry Burns, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04047264    
Other Study ID Numbers: 19-004694
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms