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Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

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ClinicalTrials.gov Identifier: NCT02540135
Recruitment Status : Withdrawn (The investigators decided not to move forward with this study at this time.)
First Posted : September 3, 2015
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
High Grade Malignant Neoplasm Glioblastoma Multiforme Anaplastic Astrocytoma Other: fluorescein Other: intraoperative MRI Not Applicable

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  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
Estimated Study Start Date : March 1, 2015
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 18, 2018


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 Name: iMRI

Active Comparator: Arm B
intraoperative MRI alone
Other: intraoperative MRI
conventional neuro-navigation and iMRI
Other Name: iMRI




Primary Outcome Measures :
  1. Extent of resection [ Time Frame: 36 hours ]
    This outcome will utilize tumor volumetry of residual enhancing tumor after resection.


Secondary Outcome Measures :
  1. Surgical time difference [ Time Frame: 36 hours ]
    This outcome will evaluate the difference in length of surgery time between each arm.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540135


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: David R Ormond, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02540135     History of Changes
Other Study ID Numbers: 15-1313
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

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

Keywords provided by University of Colorado, Denver:
high grade glioma
glioblastoma multiforme
anaplastic astrocytoma
flourescein
flourescence-guided surgery
intraoperative MRI
iMRI

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue