Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
Primary Purpose
High Grade Malignant Neoplasm, Glioblastoma Multiforme, Anaplastic Astrocytoma
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorescein
intraoperative MRI
Sponsored by
About this trial
This is an interventional other trial for High Grade Malignant Neoplasm focused on measuring high grade glioma, glioblastoma multiforme, anaplastic astrocytoma, flourescein, flourescence-guided surgery, intraoperative MRI, iMRI
Eligibility 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
Sites / Locations
- University of Colorado Anschutz Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
Flourescein plus intraoperative MRI
intraoperative MRI alone
Outcomes
Primary Outcome Measures
Extent of resection
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
Secondary Outcome Measures
Surgical time difference
This outcome will evaluate the difference in length of surgery time between each arm.
Full Information
NCT ID
NCT02540135
First Posted
September 1, 2015
Last Updated
July 18, 2018
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT02540135
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The investigators decided not to move forward with this study at this time.
Study Start Date
March 1, 2015 (Anticipated)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
July 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Malignant Neoplasm, Glioblastoma Multiforme, Anaplastic Astrocytoma
Keywords
high grade glioma, glioblastoma multiforme, anaplastic astrocytoma, flourescein, flourescence-guided surgery, intraoperative MRI, iMRI
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Flourescein plus intraoperative MRI
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
intraoperative MRI alone
Intervention Type
Other
Intervention Name(s)
fluorescein
Intervention Description
fluorescein and conventional neuro-navigation
Intervention Type
Other
Intervention Name(s)
intraoperative MRI
Other Intervention Name(s)
iMRI
Intervention Description
conventional neuro-navigation and iMRI
Primary Outcome Measure Information:
Title
Extent of resection
Description
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
Time Frame
36 hours
Secondary Outcome Measure Information:
Title
Surgical time difference
Description
This outcome will evaluate the difference in length of surgery time between each arm.
Time Frame
36 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Ormond, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
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