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.
Conditions:
🦠 Nervous System Tumor
🗓️ Study Start (Actual) 31 March 2023
🗓️ Primary Completion (Estimated) 15 February 2025
✅ Study Completion (Estimated) 15 February 2025
👥 Enrollment (Estimated) 105
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Philadelphia, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 February 2023
  • First Submitted that Met QC Criteria 17 February 2023
  • First Posted 27 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 June 2023
  • Last Update Posted 28 June 2023
  • Last Verified June 2023