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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Theodore H. Schwartz, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01767415
First received: January 10, 2013
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.

Condition Intervention Phase
Brain Tumors With Ill-defined Margins
Drug: Indigo carmine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Extent of Resection [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indigo Carmine
Intraoperative stereotactic injection of Indigo Carmine
Drug: Indigo carmine
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 Name: Indigotindisulfonate sodium

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767415

Contacts
Contact: Theodore Schwartz, MD 212-746-5620 schwarh@med.cornell.edu
Contact: Samantha Bui 212-746-1788 xeb2001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Department of Neurological Surgery Recruiting
New York, New York, United States, 10065
Contact: Theodore Schwartz, MD    212-746-5620    schwarh@med.cornell.edu   
Contact: Samantha Bui    212-746-1788    xeb2001@med.cornell.edu   
Principal Investigator: Theodore Schwartz, MD         
Sub-Investigator: Jeffrey Greenfield, MD, PhD         
Sub-Investigator: Mark Souweidane, MD         
Sub-Investigator: Philip Stieg, MD, PhD         
Sub-Investigator: Prajwal Rajappa, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Theodore Schwartz, MD Weill Medical College of Cornell University
  More Information

Responsible Party: Theodore H. Schwartz, Professor of Neurological Surgery, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01767415     History of Changes
Other Study ID Numbers: 1106011772 
Study First Received: January 10, 2013
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
brain tumor
resection
indigo carmine dye

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 24, 2016