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Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Brain Tumors With Ill-defined Margins

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Trial Information


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Extent of Resection

Outcome Description:

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

Outcome Time Frame:

48 hours

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

1106011772

NCT ID:

NCT01767415

Start Date:

March 2012

Completion Date:

Related Keywords:

  • Brain Tumors With Ill-defined Margins
  • Brain Neoplasms

Name

Location

Weill Cornell Medical College Department of Neurological SurgeryNew York, New York  10710