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

NCT01767415 | Completed Phase 1 Results

• 1 other identifier: 1106011772
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brain Tumors With Ill-defined Margins

Keywords

brain tumor; resection; indigo carmine dye

Outcome Measures

Primary Outcomes (1)

• Extent of Resection

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

  48 hours

Secondary Outcomes (1)

• Absence of Complications After Injection

  30 days

Study Arms (1)

Indigo Carmine

EXPERIMENTAL

Intraoperative stereotactic injection of Indigo Carmine

Drug: Indigo carmine

Interventions

Indigo carmine DRUG

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.

Also known as: Indigotindisulfonate sodium

Indigo Carmine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with gliomas or other tumors that may have ill defined margins during the operative resection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College Department of Neurological Surgery

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Indigo Carmine

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Anita Ou
• Organization: Weill Cornell Medicine

ano2014@med.cornell.edu

646-962-8188

Study Officials

• Theodore Schwartz, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 14, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)