Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02540135
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 40.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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
• Anticipated Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Jul 18, 2018
• Actual Study Completion Date: Jul 18, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Extent of resection [36 hours]

   This outcome will utilize tumor volumetry of residual enhancing tumor after resection.

Secondary Outcome Measures

1. Surgical time difference [36 hours]

   This outcome will evaluate the difference in length of surgery time between each arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT02540135
• Other Study ID Numbers: 15-1313
• First Posted: Sep 3, 2015
• Last Update Posted: Jul 20, 2018
• Last Verified: Jul 1, 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

Study Results

No Results Posted as of Jul 20, 2018