Second Window Indocyanine Green for All Nervous System Tumors

Phase 1

• Conditions: Nervous System Tumor
• Interventions: Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor

• Registration Number: NCT05746104
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-27
• Study Start: 2023-03-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2027-02-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SWIG Arm	Administration of Indocyanine Green (ICG) and Visualization of Tumor	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.

Primary Outcome Measures

Name	Time	Method
NIR True Positive Rate	Surgery	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%.
Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)	Surgery	SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.
NIR Efficiency	Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Positive Predictive Value	Surgery	The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.
Safety and Toxicity	Surgery	Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).
Sensitivity	Surgery	The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.
Association Between Resection Decision and Pathology	Surgery	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.
Specificity	Surgery	The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.
Negative Predictive Value	Surgery	The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.

Trial Locations

Locations (1)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States