Status:
COMPLETED
Two-Part Study to Evaluate the Safety and Efficacy of Image Guided Surgery Using Indocyanine Green for Intramolecular Imaging of Nervous System Tumors Compared to Standard of Care, (TumorGlow)
Lead Sponsor:
University of Pennsylvania
Conditions:
Brain Tumor, Primary
Brain Tumor, Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Primary malignant and non-malignant brain tumors account for an estimated 21.42 cases per 100,000 for a total count of 343,175 incident tumors based on worldwide population estimates \[1\]. These enti...
Detailed Description
Indocyanine green is a water-soluble tricarbocyanine dye routinely used in clinical settings for measuring cardiac output, hepatic function, liver blood flow and ophthalmic angiography and has been in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adult patients 18 years of age and older.
- Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment
- Good operative candidate as determined by the treating physician and multidisciplinary team
- Subject capable of giving informed consent and participating in the process of consent.
- Exclusion Criteria
- Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery
- Subjects with a history of iodide allergies
- Vulnerable patient populations
- a. Patients unable to participate in the consent process (children and neonates).
- Patients with non-MRI compatible implanted metallic foreign bodies are excluded from this study"
- Patients who due to severe claustrophobia cannot tolerate MRI scanning"
- Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium .
- Patients with moderate to end-stage renal (kidney) disease, defined as a glomerular filtration rate (GFR) less than 30 mL/day/1.73m2
Exclusion
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT03262636
Start Date
June 1 2015
End Date
March 10 2020
Last Update
August 14 2020
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