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

Phase 1

Completed

• Conditions: Brain Tumors With Ill-defined Margins
• Interventions: Drug: Indigo carmine

• Registration Number: NCT01767415
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2014-04
• Study Completion: 2014-09
• Status Verified: 2018-11
• Results First Submitted: 2018-11-26
• Results First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Results First Posted: 2018-12-11
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indigo Carmine	Indigo carmine	Intraoperative stereotactic injection of Indigo Carmine

Primary Outcome Measures

Name	Time	Method
Extent of Resection	48 hours	Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.

Secondary Outcome Measures

Name	Time	Method
Absence of Complications After Injection	30 days	Assessment of Post-operative Clinical Course \& Complications

Trial Locations

Locations (1)

Weill Cornell Medical College Department of Neurological Surgery; 🇺🇸 New York, New York, United States