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

Not Applicable

Recruiting

• Conditions: Brain Tumor Adult

• Registration Number: NCT03542409
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-31
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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.

Trial Locations

Locations (1)

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States