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

Brain Tumor Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542409
• Other study ID #: HCI77238
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: July 2026

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: Elaine Hamel
• Phone: 801-587-4720
• Email: elaine.hamel[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2026
• Est. primary completion date: October 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor Adult

Intervention

Other:
• MR Perfusion Scan
MR perfusion scan before and during surgery.
• 2HG Spectroscopy Scan
2HG spectroscopy scan before and during surgery.
• Standard of Care Intraoperative MRI
The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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