Second Window Indocyanine Green for All Nervous System Tumors

Conditions

• Nervous System Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Administration of Indocyanine Green (ICG) and Visualization of Tumor — DRUG
  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.

Study Details

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.

Key Dates

Start date

Mar 31, 2023

Status verified

Jan 2026

Primary completion

Feb 15, 2027

Completion

Feb 15, 2027

Study Design

Enrollment

105 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• 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.

Primary Outcome Measure

Tumor NIR Signal Compared to Background Brain Normal Signal (SBR) [ Time Frame: Surgery ]

Locations (1)

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