Second Window Indocyanine Green for All Nervous System Tumors

Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)

The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nervous System Tumor
• Intervention / Treatment: Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients 18 years of age and older
2. Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
3. Good operative candidates, as determined by the treating physician and multidisciplinary team
4. Subjects capable of giving informed consent

Exclusion Criteria:

1. Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
2. Subjects with a history of iodide allergies
3. Vulnerable patient populations
4. Patients unable to participate in the consent process
5. Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SWIG Arm; This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.

Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor; A single dose of the study drug, ICG, of less than 2 mg/kg will be administered on the day of surgery. The visualization of second window ICG for tumor will be performed approximately one to four hours after administration, depending on how long it takes for the neurosurgeon to get through the skin/skull or lamina/dura to the tumor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)	SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.	Surgery
NIR Efficiency	After examining the "equivocal tissue" with white light and NIR imaging, a per person success will be recorded, if least one additional specimen is resected using NIR. NIR will be considered efficacious, if significantly more than 10% of patients meet the success criteria. Each histology will be tested separately.	Surgery
NIR True Positive Rate	Of the additionally resected specimens using NIR, we will find the true positive rate based on pathology. The entire sample will be evaluated jointly; then, each histology will be evaluated separately as there may be multiple specimens per patient surgery. NIR will be considered efficacious if the true positive rate is significantly greater than 50%.	Surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Toxicity	Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).	Surgery
Association Between Resection Decision and Pathology	Test for an association between a change in resection decision (yes/no) and the pathology results for all resected equivocal tissues will be completed. The association will be tested unadjusted and after controlling tumor location stratified by histology.	Surgery
Sensitivity	The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.	Surgery
Specificity	The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.	Surgery
Positive Predictive Value	The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.	Surgery
Negative Predictive Value	The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.	Surgery

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Site; Neoplasms; Nervous System Neoplasms
• Other Study ID Numbers: UPCC 14321; 850516 (Other Identifier: University of Pennsylvania)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes