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 January 2013 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: NA
Last verified: January 2013
History: No changes posted
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

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.

  • Absence of complications after injection [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indigo Carmine
Intraoperative stereotactic injection of Indigo Carmine
Drug: Indigo carmine
Other Name: Indigotindisulfonate sodium

  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: Konstantinos Margetis, MD 212-746-2363 ext 2 kom2001@med.cornell.edu
Contact: Tamika Wong 212-746-1788 taw2015@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: Konstantinos Margetis, MD       kom2001@med.cornell.edu   
Principal Investigator: Theodore Schwartz, MD         
Sub-Investigator: Jeffrey Greenfield, MD, PhD         
Sub-Investigator: Konstantinos Margetis, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
  More Information

No publications provided

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: January 10, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 27, 2014