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

Sponsor

University of Utah (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03542409

Collaborator

(none)

Enrollment

Location

Arms

67.5

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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. Participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Adult	Other: MR Perfusion Scan Other: 2HG Spectroscopy Scan	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 15, 2017

Actual Primary Completion Date :

Oct 28, 2021

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: 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.

Arm

Intervention/Treatment

Experimental: 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: 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.

Outcome Measures

Primary Outcome Measures

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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Ability to comply with study and follow-up 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsman Cancer Institute	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

University of Utah

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Utah

ClinicalTrials.gov Identifier:

NCT03542409

Other Study ID Numbers:

HCI77238

First Posted:

May 31, 2018

Last Update Posted:

Feb 7, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 7, 2022