Second Window Indocyanine Green for All Nervous System Tumors

NCT ID: NCT05746104

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2027-02-15

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.

Conditions

Nervous System Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Administration of Indocyanine Green (ICG) and Visualization of Tumor

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

850516

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 14321

Identifier Type: -

Identifier Source: org_study_id