- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767415
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
November 26, 2018 updated by: Weill Medical College of Cornell University
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College Department of Neurological Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Indigo Carmine
Intraoperative stereotactic injection of 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extent of Resection
Time Frame: 48 hours
|
Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absence of Complications After Injection
Time Frame: 30 days
|
Assessment of Post-operative Clinical Course & Complications
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Theodore Schwartz, MD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 10, 2013
First Posted (Estimate)
January 14, 2013
Study Record Updates
Last Update Posted (Actual)
December 11, 2018
Last Update Submitted That Met QC Criteria
November 26, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1106011772
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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