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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor Adult
• Intervention / Treatment: Other: MR Perfusion Scan; Other: 2HG Spectroscopy Scan; Other: Standard of Care Intraoperative MRI

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elaine Hamel; Phone Number: 801-587-4720; Email: elaine.hamel@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute
      • Contact: Elaine Hamel; Phone Number: 801-587-4720; Email: elaine.hamel@hci.utah.edu
      • Principal Investigator: Randy Jensen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: MR Perfusion Scan; MR perfusion scan before and during surgery.
Experimental: 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.	Other: 2HG Spectroscopy Scan; 2HG spectroscopy scan before and during surgery.
Experimental: 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).	Other: Standard of Care Intraoperative MRI; The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Imaging Completion	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.	1 day
Incidence of Patient Complications Following Tumor Resection	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)	1 year

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Estimated): October 28, 2024
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 17, 2018
• First Posted (Actual): May 31, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HCI77238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No