Brain Tumors With Ill-defined Margins
Conditions
Keywords
brain tumor, resection, indigo carmine dye
Brief summary
The purpose of this study is to investigate whether stereotactic indigo carmine injection can safely increase the extent of tumor resection.
Detailed description
Low grade gliomas are brain tumors with usually poorly defined borders between tumor and normal brain. This characteristic of low grade gliomas makes the gross total resection of the tumor extremely difficult. Nevertheless, several studies have demonstrated that the risk of recurrence and progression into a more malignant tumor can be decreased with a more aggressive surgical resection. An aggressive attempt to achieve a gross total resection may result in the resection of normal brain and therefore neurological injury. For this reason, the more common error is to subtotally resect the tumor leaving significant volumes of tumor behind. Many techniques have been introduced to safely increase the extent of resection, since the extent of resection is associated with a higher survival rate. Each one of these techniques has several shortcomings. The current study will assess whether the intraoperative stereotactic injection of the indigo carmine at the tumor margins helps to safely increase of extent of tumor resection. In the first step of the study the safety and the correlation between resection of stained tissue/extend of tumor resection will be assessed. If the results are satisfactory, then the second step will ensue. In the second step we will assess the utility of indigo carmine as an additional adjunct to guide tumor resection.
Interventions
DRUGIndigo 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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Resection | 48 hours | Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Complications After Injection | 30 days | Assessment of Post-operative Clinical Course & Complications |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Indigo Carmine |
|---|---|
| Age, Continuous | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
| Tumor Diagnosis Headache | 1 Participants |
| Tumor Diagnosis Incidental finding | 3 Participants |
| Tumor Diagnosis Neurological Defect | 2 Participants |
| Tumor Diagnosis Recurrent Disease | 3 Participants |
| Tumor Diagnosis Seizures | 1 Participants |
| Tumor Location Lt Frontal | 2 Participants |
| Tumor Location Lt Occipital | 2 Participants |
| Tumor Location Lt parietal | 1 Participants |
| Tumor Location Lt Temporal | 1 Participants |
| Tumor Location Rt frontal | 2 Participants |
| Tumor Location Rt occipital | 1 Participants |
| Tumor Location Rt parietal | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Extent of Resection
Evaluation of the extent of resection of the tumor following the indigo carmine infusion to the tumor.
Time frame: 48 hours
Population: intraoperative stereotactic injection of indigo carmine at the tumor margins
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Indigo Carmine | Extent of Resection | 97.1 percentage of tumor resected |
Secondary
Absence of Complications After Injection
Assessment of Post-operative Clinical Course & Complications
Time frame: 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Indigo Carmine | Absence of Complications After Injection | Infection | 1 Participants |
| Indigo Carmine | Absence of Complications After Injection | Hempiaresis | 1 Participants |
| Indigo Carmine | Absence of Complications After Injection | Mild Word-finding difficulties | 1 Participants |
| Indigo Carmine | Absence of Complications After Injection | No complications (good clinical course) | 7 Participants |