Trial Outcomes & Findings for Intra-operative Use of Indigo Carmine Dye for the Delineation of Ill Defined Tumor Borders Using Stereotactic Injection (NCT NCT01767415)

NCT ID: NCT01767415

Last Updated: 2018-12-11

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2018-12-11

Participant Flow

Participant milestones

Measure	Indigo Carmine Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Indigo Carmine n=10 Participants Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.
Age, Continuous	49 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Tumor Location Lt Temporal	1 Participants n=5 Participants
Tumor Location Lt Frontal	2 Participants n=5 Participants
Tumor Location Rt frontal	2 Participants n=5 Participants
Tumor Location Lt Occipital	2 Participants n=5 Participants
Tumor Location Rt parietal	1 Participants n=5 Participants
Tumor Location Rt occipital	1 Participants n=5 Participants
Tumor Location Lt parietal	1 Participants n=5 Participants
Tumor Diagnosis Incidental finding	3 Participants n=5 Participants
Tumor Diagnosis Recurrent Disease	3 Participants n=5 Participants
Tumor Diagnosis Seizures	1 Participants n=5 Participants
Tumor Diagnosis Headache	1 Participants n=5 Participants
Tumor Diagnosis Neurological Defect	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: intraoperative stereotactic injection of indigo carmine at the tumor margins

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

Outcome measures

Measure

Indigo Carmine n=10 Participants Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.

Extent of Resection

97.1 percentage of tumor resected Interval 91.0 to 100.0

SECONDARY outcome

Timeframe: 30 days

Assessment of Post-operative Clinical Course & Complications

Outcome measures

Measure	Indigo Carmine n=10 Participants Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.
Absence of Complications After Injection Infection	1 Participants
Absence of Complications After Injection Hempiaresis	1 Participants
Absence of Complications After Injection Mild Word-finding difficulties	1 Participants
Absence of Complications After Injection No complications (good clinical course)	7 Participants

Adverse Events

Indigo Carmine

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure

Indigo Carmine n=10 participants at risk Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.

Infections and infestations Staphylococcus aureus infection (brain abscess)

10.0% 1/10 • Number of events 1

Other adverse events

Measure

Indigo Carmine n=10 participants at risk Intraoperative stereotactic injection of Indigo Carmine Indigo carmine: 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.

Nervous system disorders hemiparesis

10.0% 1/10 • Number of events 1

Additional Information

Anita Ou

Weill Cornell Medicine

Phone: 646-962-8188

Email: ano2014@med.cornell.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place