Phase 2
Completed N=10
Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection
Source: ClinicalTrials.gov NCT01767415 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Dec 2018
Primary outcomePrimary: Extent of Resection — 97.1 percentage of tumor resected
Summary
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Extent of Resection |
97.1 | — |
| SECONDARY Absence of Complications After Injection |
1; 1; 1; 7 | — |
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. Informational only — not medical advice.