Second Window Indocyanine Green for All Nervous System Tumors

Phase 1Enrolling By InvitationNCT05746104

Abramson Cancer Center at Penn Medicine105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

105

Conditions

Nervous System Tumor

Interventions

Administration of Indocyanine Green (ICG) and Visualization of TumorDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Surgery

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.

Time frame: Surgery

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%.

Time frame: Surgery

Secondary Outcomes

Safety and Toxicity

Safety and toxicity will be evaluated by review of vital signs and any reported or observed adverse events (AEs).

Time frame: Surgery

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.

Time frame: Surgery

Sensitivity

The ROC curve will be analyzed, and the sensitivity, with its respective confidence intervals, will be estimated.

Data from ClinicalTrials.gov

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