Imaging of Central Nervous System Tumors Using Indocyanine Green (TumorGlow - CNS)
Recruiting
18 years - 99 years
All
Phase
1
100 participants needed
1 Location
Brief description of study
The research study is being conducted to determine if a same-day intravenous (into a vein) injection of indocyanine green (ICG) detected using an imaging system, can be a useful tool in identifying and differentiating tumor tissue from normal tissues.
Detailed description of study
To measure tumor near infrared signal with the standard dose (2 mg/kg) and same day imaging of brain tumors. The surgeon will determine whether there is a part of the resection bed where there is equivocal tissue where the surgeon is not sure whether it is tumor or not. Compare second window ICG residual near infrared dye signal at the completion of surgical resection of contrast-enhancing brain tumors to the postoperative gadolinium-enhanced MRI which is performed within 24 hours of surgery as standard of care. The primary end-point of the study is to determine the near infrared signal and test characteristics (i.e., sensitivity, specificity, positive predictive value, negative predictive value) of second window indocyanine green in detection of tumors using intraoperative NIR imaging as compared to the standard of care histopathology report. Clinically Significant Event, such as If the surgeon identifies equivocal tissue, the surgeon will code it as yes/no/not sure based on white light alone. To compare second window ICG residual near infrared dye signal at the completion of surgical resection of contrast-enhancing brain tumors to the postoperative gadolinium-enhanced MRI which is performed within 24 hours of surgery as standard of care.
Other important endpoints include safety and toxicity that includes review of vital signs and any reported or observed AE
Eligibility of study
You may be eligible for this study if you meet the following criteria:
Conditions:Medical Research, Central Nervous System, Tumors, Brain, Spine
Age:
18 years - 99 years
Gender: All
Patients having brain or spine (nervous system) tumor surgery