Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
| Status: | Withdrawn |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/22/2018 |
| Start Date: | March 1, 2015 |
| End Date: | July 18, 2018 |
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.
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.
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.
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.
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
We found this trial at
1
site
13001 E 17th Pl
Aurora, Colorado 80045
Aurora, Colorado 80045
(303) 724-5000
University of Colorado Anschutz Medical Campus Located in the Denver metro area near the Rocky...
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