Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Brain Tumor Adult
- Sponsor
- University of Utah
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Incidence of Patient Complications Following Tumor Resection
- Status
- Active, not recruiting
- Last Updated
- 5 months ago
Overview
Brief Summary
This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.
Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.
Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Suspected glioma (grade II, III, or IV)
- •Preoperative MR perfusion (enhancing tumors)
- •Preoperative MR 2-HG spectroscopy (nonenhancing tumors)Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
- •Karnofsky performance status ≥ 60
- •Life expectancy \> 12 weeks
- •Cohort 1: Ability to comply with study and follow-up procedures
- •Cohort 2: Ability to comply with study procedures
Exclusion Criteria
- •Prior diagnosis of intracranial glioma
- •Other malignancy with expected need for systemic therapy within 3 years
- •Inability to have 6000 grays of radiation to the brain
- •Need for urgent palliative intervention for primary disease (e.g., impending herniation)
- •Evidence of bleeding diathesis or coagulopathy
- •History of intracerebral abscess within 6 months prior to Day 0
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- •Pregnant females
- •Subjects unable to undergo an MRI with contrast
Outcomes
Primary Outcomes
Incidence of Patient Complications Following Tumor Resection
Time Frame: 1 year
Any surgical complications at post-op, hospital discharge, 1-month, 3-months, 6-months, and 1 year following surgery using the Common Terminology Criteria for Adverse Events (CTCAE)
Intraoperative Imaging Completion
Time Frame: 1 day
This is a feasibility study to see whether advanced imaging modalities can be used intraoperatively so the primary outcome is a yes/no regarding completion of imaging.