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

Primary Purpose

Brain Tumors With Ill-defined Margins

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indigo carmine
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors With Ill-defined Margins focused on measuring brain tumor, resection, indigo carmine dye

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College Department of Neurological Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Indigo Carmine

Arm Description

Intraoperative stereotactic injection of Indigo Carmine

Outcomes

Primary Outcome Measures

Extent of Resection
Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.

Secondary Outcome Measures

Absence of Complications After Injection
Assessment of Post-operative Clinical Course & Complications

Full Information

First Posted
January 10, 2013
Last Updated
November 26, 2018
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01767415
Brief Title
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Official Title
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors With Ill-defined Margins
Keywords
brain tumor, resection, indigo carmine dye

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Indigo Carmine
Arm Type
Experimental
Arm Description
Intraoperative stereotactic injection of Indigo Carmine
Intervention Type
Drug
Intervention Name(s)
Indigo carmine
Other Intervention Name(s)
Indigotindisulfonate sodium
Intervention Description
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.
Primary Outcome Measure Information:
Title
Extent of Resection
Description
Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Absence of Complications After Injection
Description
Assessment of Post-operative Clinical Course & Complications
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore Schwartz, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College Department of Neurological Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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