Status:
COMPLETED
Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma
Lead Sponsor:
Andrew Sloan, MD
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Imaging procedures that use aminolevulinic acid (ALA) may help find and diagnose residual tumor in participants with grade IV malignant astrocytoma who are undergoing surgery to remove the ...
Detailed Description
OBJECTIVES: Primary * Assess 2 doses of 5-ALA, 10kg/mg and 20kg/mg, to determine the optimum ALA dose in terms of both sensitivity and specificity for residual tumor. We will compare residual tumor ...
Eligibility Criteria
Inclusion
- Tumor Pathology: Newly diagnosed or recurrent malignant gliomas WHO grade IV
- Location: Supratentorial
- Resection: Tumor must be judged suitable for resection on the basis of imaging studies.
- Consent: Participants must be able to give written, informed consent as approved by the local IRB
- Newly Diagnosed Tumors: Participants with newly diagnosed Grade IV glioma who have had not been previously treated with cranial radiation therapy
- Recurrent Tumors: Participants with recurrent Grade IV gliomas who have failed cranial radiation therapy
Exclusion
- Pregnant women or those who are breast feeding
- Individuals with history of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
- Individuals with history of liver disease in last 12 months
- Individuals with AST, ALT, ALP, or bilirubin \>2.5x normal upper limit any time during the previous 2 months
- Individuals with plasma creatinine\>180 μmol/L
- Individuals who are unable to comply with photosensitivity precautions
- Individuals without a grade IV glioma
Key Trial Info
Start Date :
December 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2018
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00752323
Start Date
December 8 2009
End Date
October 14 2018
Last Update
September 17 2021
Active Locations (1)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065