A Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain (ALA)
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|ClinicalTrials.gov Identifier: NCT01403311|
Recruitment Status : Unknown
Verified March 2014 by Jefferson W Chen, MD, Legacy Health System.
Recruitment status was: Active, not recruiting
First Posted : July 27, 2011
Last Update Posted : March 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: 5-Aminolevuline Acid||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||March 2015|
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403311
|United States, Oregon|
|Legacy Health System|
|Portland, Oregon, United States, 97210|
|Principal Investigator:||Jefferson Chen, MD, PhD||Legacy Health System|