Clinical Trial Details
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NCT00752323 : Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- 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

- Consent: Patients must be able to give written, informed consent as approved by the
local IRB

- Newly Diagnosed Tumors: Patients with newly diagnosed Grade IV glioma who have had not
been previously treated with cranial radiation therapy

- Recurrent Tumors: Patients with recurrent Grade IV gliomas who have failed cranial
radiation therapy

Exclusion Criteria:

- 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
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