Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation

Conditions
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Brain Tumor Adult

Intervention / Treatment
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* Other: MR Perfusion Scan
* Other: 2HG Spectroscopy Scan
* Other: Standard of Care Intraoperative MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1, Group A (contrast enhancing tumor)<br>Group A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection. | Other: MR Perfusion Scan<br>* MR perfusion scan before and during surgery.<br>|
| Experimental: Cohort 1, Group B (non-enhancing tumor)<br>Group B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection. | Other: 2HG Spectroscopy Scan<br>* 2HG spectroscopy scan before and during surgery.<br>|
| Experimental: Cohort 2<br>During the analysis for cohort 1, we found significant differences in the pre MRI samples and the post intraoperative MRI samples. Cohort 2, which will include 10 additional patients, has be created to confirm these differences. Unlike cohort 1, advanced imaging (2-HG spectroscopy and MR perfusion) is not needed to make this comparison. The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. The specific aim of Cohort 2 is: 1. Compare areas from initial surgery with that of extended resection after intraoperative SOC MRI in 10 additional subjects (Cohort 2). | Other: Standard of Care Intraoperative MRI<br>* The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Imaging Completion | 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. | 1 day | 
| Incidence of Patient Complications Following Tumor Resection | 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) | 1 year |