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Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain

2014-08-27 03:13:58 | BioPortfolio

Summary

The prodrug, 5-Aminolevulinic acid (ALA), has been shown to lead to intracellular accumulation of fluorescent porphyrins in high grade malignant gliomas in the brain. On imaging, this accumulation of fluorescent porphyrins helps delineate tumor borders, resulting in the surgeon being better able to visualize and thus able to make a complete, or near-complete resection of the tumor.

Description

The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of fluorescent porphyrins in malignant gliomas will be used under investigation for identification and resection of high grade gliomas. Surgery will be done using a modified neurosurgical microscope, with a fluorescent kit that enables switching from the conventional white light to a violet-blue excitation light for visualization during tumor resection. If deemed safe by the neurosurgeon, any area of the resection bed determined to be fluorescence-positive for tumor will be removed with appropriate designation of tissue for histopathological evaluation. After this resection, additional fluorescence images will be obtained and the process repeated until the image is negative for tumor. At all times, the decision to resect will be limited by clinical judgment of safety.

The desire is that a more complete resection will occur due to the surgeon's ability to better visualize and distinguish between tumor and normal tissue, and thus be able to remove as much, or most of, the tumorous tissue, resulting in a better outcome for the patient, or for future patients.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioma

Intervention

5-Aminolevuline Acid

Location

UCSF Department of Neurosurgery
San Francisco
California
United States
94143

Status

Not yet recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:58-0400

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Medical and Biotech [MESH] Definitions

A fatty acid-binding protein expressed by ASTROCYTES during CENTRAL NERVOUS SYSTEM development, and by MALIGNANT GLIOMA cells. It is also expressed by ASTROCYTES in response to injury or ISCHEMIA, and may function in repair of the MYELIN SHEATH.

A malignant BRAINSTEM neoplasm of the PONS. They are more commonly found in children than adults.

A BRAIN-specific hyalectin that may play a role in terminally differentiating NEURONS. It is found highly overexpressed in primary BRAIN TUMORS and in experimental models of GLIOMA.

Carbonic acid (H2C03). The hypothetical acid of carbon dioxide and water. It exists only in the form of its salts (carbonates), acid salts (hydrogen carbonates), amines (carbamic acid), and acid chlorides (carbonyl chloride). (From Grant & Hackh's Chemical Dictionary, 5th ed)

A 20-carbon-chain fatty acid, unsaturated at positions 8, 11, and 14. It differs from arachidonic acid, 5,8,11,14-eicosatetraenoic acid, only at position 5.

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