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

NCT ID: NCT03542409

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2026-07-31

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.

Conditions

Brain Tumor Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1, Group A (contrast enhancing tumor)

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.

Group Type: EXPERIMENTAL

MR Perfusion Scan

Intervention Type: OTHER

MR perfusion scan before and during surgery.

Cohort 1, Group B (non-enhancing tumor)

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.

Group Type: EXPERIMENTAL

2HG Spectroscopy Scan

Intervention Type: OTHER

2HG spectroscopy scan before and during surgery.

Cohort 2

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).

Group Type: EXPERIMENTAL

Standard of Care Intraoperative MRI

Intervention Type: OTHER

The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.

Interventions

MR Perfusion Scan

MR perfusion scan before and during surgery.

Intervention Type: OTHER

2HG Spectroscopy Scan

2HG spectroscopy scan before and during surgery.

Intervention Type: OTHER

Standard of Care Intraoperative MRI

The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

HCI77238

Identifier Type: -

Identifier Source: org_study_id