Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma

• Status: Completed
• Trial end date: 2018-10-14
• Target enrollment: 0
• Participant gender: All

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 tumor.

PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of malignant brain tumor through image- guided fluorescence localization. We hypothesize that the use of qualitative fluorescence imaging and point PpIX concentration quantification will enable more complete tumor resection than normal direct (i.e., white light) visualization, and thereby improve participant survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Andrew Sloan, MD; Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aminolevulinic Acid

Criteria

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 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 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