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

Phase 1 & 2
Waitlist Available
Led By Theodore Schwartz, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Subjects with gliomas or other tumors that may have ill defined margins during the operative resection.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

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

Eligible Conditions
  • Brain Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Extent of Resection
Secondary study objectives
Absence of Complications After Injection

Side effects data

From 2017 Phase 4 trial • 480 Patients • NCT01607255
1%
post polypectomy abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Air Method
Water (Exchange) Method
Water (Exchange) Plus Dye Method

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Indigo CarmineExperimental Treatment1 Intervention
Intraoperative stereotactic injection of Indigo Carmine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indigotindisulfonic acid
FDA approved

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,776 Total Patients Enrolled
Theodore Schwartz, MDPrincipal InvestigatorWeill Medical College of Cornell University
~1 spots leftby Dec 2025
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