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

Utah System of Higher Education (USHE)

Status: Active, not recruiting

Conditions: Brain Tumor Adult

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03542409

HCI77238

Details and patient eligibility

About

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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 3 patient groups

Cohort 1, Group A (contrast enhancing tumor)

Experimental group

Description:

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.

Treatment:

Other: MR Perfusion Scan

Cohort 1, Group B (non-enhancing tumor)

Experimental group

Description:

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.

Treatment:

Other: 2HG Spectroscopy Scan

Cohort 2

Experimental group

Description:

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).

Treatment:

Other: Standard of Care Intraoperative MRI