Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 65
Updated:12/13/2018
Start Date:April 2012
End Date:September 2014

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The purpose of this study is to investigate whether stereotactic indigo carmine injection can
safely increase the extent of tumor resection.

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.

Inclusion Criteria:

- Subjects with gliomas or other tumors that may have ill defined margins during the
operative resection.

Exclusion Criteria:

- Subjects with a contraindication for brain MRI scan. Subjects who are pregnant,
younger than 18 years old or have a contraindication for indigo carmine are excluded
as well
We found this trial at
1
site
New York, New York 10710
Principal Investigator: Theodore Schwartz, MD
Phone: 212-746-5620
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from
New York, NY
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