NCT05746104

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)

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nervous System Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-03-31
• Primary completion: 2027-02-15
• Completion: 2027-02-15
• First posted: 2023-02-27
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study