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Trial Title:
Second Window Indocyanine Green for All Nervous System Tumors
NCT ID:
NCT05746104
Condition:
Nervous System Tumor
Conditions: Official terms:
Nervous System Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Administration of Indocyanine Green (ICG) and Visualization of Tumor
Description:
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.
Arm group label:
SWIG Arm
Summary:
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pennsylvania Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Start date:
March 31, 2023
Completion date:
February 15, 2027
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746104
