CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Indigo carminedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01767415
NCT01767415Phase 2Completed
CompareCT.gov

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

Weill Medical College of Cornell University·interventional·Posted Jan 14, 2013·Updated Dec 11, 2018

In Brief

A Phase 2 clinical trial evaluating Indigo carmine for Brain Tumors With Ill-defined Margins. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Tumors With Ill-defined Margins
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2013
Enrollment StartApr 1, 2012
Primary CompletionApr 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 13.5 years ago

Interventions

Indigo carminedrug

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.