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Enrolling by Invitation

NCT Number: NCT05746104

Second Window Indocyanine Green for All Nervous System Tumors

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.

Enrolling by Invitation

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Key information

Conditions

Nervous System Tumor Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients 18 years of age and older
  • Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
  • Good operative candidates, as determined by the treating physician and multidisciplinary team
  • Subjects capable of giving informed consent

Exclusion criteria

  • Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
  • Subjects with a history of iodide allergies
  • Vulnerable patient populations
  • Patients unable to participate in the consent process
  • Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)

Treatment and study plan

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.

Primary outcomes

  1. Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)

    Time frame: Surgery

    SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.

  2. NIR Efficiency

    Time frame: Surgery

    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.

  3. NIR True Positive Rate

    Time frame: Surgery

    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%.

Secondary outcomes

  1. Safety and Toxicity

    Time frame: Surgery

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

  2. Association Between Resection Decision and Pathology

    Time frame: Surgery

    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.

  3. Sensitivity

    Time frame: Surgery

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

  4. Specificity

    Time frame: Surgery

    The ROC curve will be analyzed, and the specificity, with their respective confidence intervals, will be estimated.

  5. Positive Predictive Value

    Time frame: Surgery

    The ROC curve will be analyzed, and the positive predictive value, with their respective confidence intervals, will be estimated.

  6. Negative Predictive Value

    Time frame: Surgery

    The ROC curve will be analyzed, and the negative predictive value, with their respective confidence intervals, will be estimated.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Intraoperative Molecular Imaging of Central Nervous System Tumors Using Same Day Second Window Imaging With Indocyanine Green (TumorGlow™ - CNS)

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2023
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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