Weill Cornell Medical College Department of Neurological Surgery
New York, 10065, United States
NCT Number: NCT01767415
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1 / Phase 2
New York, 10065, United States
Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.
Other names: Indigotindisulfonate sodium
Time frame: 48 hours
Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.
Time frame: 30 days
Assessment of Post-operative Clinical Course & Complications
Weill Medical College of Cornell University
Other
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