Expired Study
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Aurora, Colorado 80045


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

15-1313


NCT ID:

NCT02540135


Secondary ID:


Study Acronym:


Brief Title:

Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma


Official Title:

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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Colorado, Denver


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

The investigators decided not to move forwar


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:March 1, 2015
Completion Date:July 18, 2018
Completion Type:Actual
Primary Completion Date:July 18, 2018
Primary Completion Type:Actual
Verification Date:July 2018
Last Changed Date:July 18, 2018
First Received Date:September 1, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Surgical time difference
Time Frame:36 hours
Safety Issues:False
Description:This outcome will evaluate the difference in length of surgery time between each arm.
Outcome Type:Primary Outcome
Measure:Extent of resection
Time Frame:36 hours
Safety Issues:False
Description:This outcome will utilize tumor volumetry of residual enhancing tumor after resection.

Study Interventions

Intervention Type:Other
Name:fluorescein
Description:fluorescein and conventional neuro-navigation
Arm Name:Arm A
Intervention Type:Other
Name:intraoperative MRI
Description:conventional neuro-navigation and iMRI
Arm Name:Arm A
Other Name:iMRI

Study Arms

Study Arm Type:Active Comparator
Arm Name:Arm B
Description:intraoperative MRI alone
Study Arm Type:Experimental
Arm Name:Arm A
Description:Flourescein plus intraoperative MRI

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Colorado, Denver

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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