A Phase 2 interventional study of 5-Aminolevuline Acid in Glioma, sponsored by Legacy Health System. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-03-26.
Sponsored by Legacy Health System · Phase 2, Interventional, and Treatment
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.
1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's planned enrollment of 18 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →Legacy Health System is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
5-Aminolevuline Acid (ALA)
Drug: 5-Aminolevuline Acid
5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
Establish a safe dose to provide optimal discrimination between normal and malignant tissue for oral ALA administration intraoperatively
Time frame: participants will be followed while in the hospital and for 12 weeks after surgery
Compare time-to-progression and survival to that in comparable cases performed without the aid of ALA
Time frame: participants will be followed for 24 months
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Legacy Health System