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Enrolling by invitation NCT05746104

Second Window Indocyanine Green for All Nervous System Tumors

Phase I Interventional Nervous System Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Administration of Indocyanine Green (ICG) and Visualization of Tumor.
Who it may be relevant to
Registry conditions: Nervous System Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug 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.

Primary outcome measures

  • Tumor NIR Signal Compared to Background Brain Normal Signal (SBR) [Time frame: Surgery]
  • NIR Efficiency [Time frame: Surgery]
  • NIR True Positive Rate [Time frame: Surgery]
Secondary outcome measures (6)
  • Safety and Toxicity [Time frame: Surgery]
  • Association Between Resection Decision and Pathology [Time frame: Surgery]
  • Sensitivity [Time frame: Surgery]
  • Specificity [Time frame: Surgery]
  • Positive Predictive Value [Time frame: Surgery]
  • Negative Predictive Value [Time frame: Surgery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Pennsylvania Hospital — Philadelphia

Identifiers

NCT: NCT05746104 · UPCC 14321 · 850516

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗