Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
Withdrawn before enrolling · Not applicable
Conditions studied: High Grade Malignant Neoplasm, Glioblastoma Multiforme, Anaplastic Astrocytoma
In brief
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.
Key facts
- Study ID
- NCT02540135
- Run by
- University of Colorado, Denver
- People needed
- 0
- Starts
- 2015-03-01
- Expected to finish
- 2018-07-18
- Last updated by the study team
- 2018-07-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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