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| Name | Class |
|---|---|
| DUSA Pharmaceuticals, Inc. | INDUSTRY |
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing malignant brain tumors during surgery.
This study aims to determine the safety and utility of using 5-Aminolevulinic Acid (ALA) in removing brain tumors during surgery. When ALA is provided at an increased concentration, protoporphorin concentration in the malignant cell increases and renders the cell fluorescent under long ultraviolet light. This study looks at using oral ALA to help identify the tumor cells intraoperatively and facilitate complete resection.
Oral ALA will be given prior to image-guided microsurgical resection of the tumor. Following tumor resection under light microscopy, the tumor bed will be illuminated and any residual fluorescent tissue in cavity will be surgically removed leading to a more complete resection of tumor. Pathologic confirmation of tumor type will be made by neuropathology. Photosensitizer concentration in malignant and normal tissue will be estimated by fluorescence microscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALA | Experimental | 5-Aminolevuline Acid (ALA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-Aminolevuline Acid | Drug | 5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively | participants will be followed while in the hospital and for 12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA | participants will be followed for 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jefferson Chen, MD, PhD | Legacy Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Legacy Health System | Portland | Oregon | 97210 | United States |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D009837 | Oligodendroglioma |
| D008527 | Medulloblastoma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D018242 | Neuroectodermal Tumors, Primitive |