Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

July 18, 2018 updated by: University of Colorado, Denver

Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma

This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.

Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.

This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.

For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.

Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
  • Eligible for gross total resection of enhancing component of tumor
  • Karnofsy performance status >/= 70%

Exclusion Criteria:

  • Presence of multi-focal disease
  • Disease that crosses the mid-line
  • History of adverse reaction to flourescein
  • Known ongoing pregnancy
  • Inability to grant consent
  • Contraindication to perform iMRI
  • Contraindication to flourescein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Flourescein plus intraoperative MRI
Other: fluorescein
fluorescein and conventional neuro-navigation
Other: intraoperative MRI
conventional neuro-navigation and iMRI
Other Names:
  • iMRI
Active Comparator: Arm B
intraoperative MRI alone
Other: intraoperative MRI
conventional neuro-navigation and iMRI
Other Names:
  • iMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of resection
Time Frame: 36 hours
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
36 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical time difference
Time Frame: 36 hours
This outcome will evaluate the difference in length of surgery time between each arm.
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: David R Ormond, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2015

Primary Completion (Actual)

July 18, 2018

Study Completion (Actual)

July 18, 2018

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-1313

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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