Status:
COMPLETED
Fluorescence-guided Surgery for Low- and High-grade Gliomas
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Gliomas are the most common primary brain tumor, yet remain a challenge to effectively treat. Mounting evidence suggests that survival improves with greater tumor removal, yet being able do a complete...
Detailed Description
Gliomas are the most common primary brain tumor, yet are associated with a 12-14 month overall survival in the United States. Mounting evidence suggests that survival improves with greater extent of r...
Eligibility Criteria
Inclusion
- Presumed newly-diagnosed supratentorial glioma (previous biopsy-only/no adjuvant therapy are eligible for randomization)
- Age \> 18 years
- Normal bone marrow function (WBC \> 3000, Platelets \> 100,000)
Exclusion
- Infratentorial tumors
- Pregnancy
- Hypersensitivity to 5-aminolevulinic acid hydrochloride or porphyrins
- History of photosensitivity, porphyria, or exfoliative dermatitis
- Hepatic dysfunction in the last 12 months (defined by AST, ALT, ALP, bilirubin \> 2.5 x normal)
- Serum creatinine \> 180 µmol/L
- Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2
- Inability to undergo MRI scan with contrast
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01502280
Start Date
November 1 2010
End Date
June 1 2018
Last Update
November 24 2023
Active Locations (1)
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1
St. Joseph's Hospital and Medical Center/Barrow Neurological Institute
Phoenix, Arizona, United States, 85013