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

Not Applicable

Recruiting

Interventions: Other: 2HG Spectroscopy Scan
Other: MR Perfusion Scan
Other: Standard of Care Intraoperative MRI

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Cohort 1, Group B (non-enhancing tumor)	2HG Spectroscopy Scan	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.
Cohort 1, Group A (contrast enhancing tumor)	MR Perfusion Scan	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.
Cohort 2	Standard of Care Intraoperative MRI	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).

Primary Outcome Measures

Name	Time	Method
Incidence of Patient Complications Following Tumor Resection	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	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.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Huntsman Cancer Institute
🇺🇸
Salt Lake City, Utah, United States

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