Second Window Indocyanine Green for All Nervous System Tumors

Nervous System Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746104
• Other study ID #: UPCC 14321
• Secondary ID: 850516
• Status: Recruiting
• Phase: Phase 1
• Start date: March 31, 2023
• Est. completion date: February 15, 2025

Study information

• Verified date: June 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Marie Kerr, CCRP
• Phone: 215-829-6720
• Email: marie.kerr[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: February 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nervous System Neoplasms
• Nervous System Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Safety and Toxicity	Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).	Surgery
Secondary	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
Secondary	Sensitivity	The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.	Surgery
Secondary	Specificity	The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.	Surgery
Secondary	Positive Predictive Value	The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.	Surgery
Secondary	Negative Predictive Value	The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.	Surgery