Phase 2
N=10
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Brain Tumors With Ill-defined Margins
Bottom Line
View on ClinicalTrials.gov: NCT01767415 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Dec 2018
Primary outcome: Primary: Extent of Resection — 97.1 percentage of tumor resected
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Indigo carmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Resection |
97.1 | — |
| SECONDARY Absence of Complications After Injection |
1; 1; 1; 7 | — |
Summary
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01767415). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.