Second Window Indocyanine Green for All Nervous System Tumors

Abramson Cancer Center at Penn Medicine

Status and phase: Invitation-only; Phase 1

Conditions: Nervous System Tumor

Treatments: Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT05746104

UPCC 14321

850516

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

SWIG Arm

Experimental group

Description:

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.

Treatment:

Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor