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Completed

NCT Number: NCT03542409

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

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.

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Key information

Conditions

Brain Tumor Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Perfusion Scan

Device

MR perfusion scan before and during surgery.

2HG Spectroscopy Scan

Device

2HG spectroscopy scan before and during surgery.

Standard of Care Intraoperative MRI

Device

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

Primary outcomes

  1. Intraoperative Imaging Completion

    Time frame: 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.

  2. Incidence of Patient Complications Following Tumor Resection

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2025
First posted
May 31, 2018
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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