Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain (ALA)
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|ClinicalTrials.gov Identifier: NCT01116661|
Recruitment Status : Recruiting
First Posted : May 5, 2010
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: 5-Aminolevuline Acid||Phase 2|
The drug, 5-aminolevulinic acid (ALA), which leads to intracellular accumulation of fluorescent porphyrins in gliomas will be used under investigation for identification and resection of high and low 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 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 Tumors of the Brain|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
Drug: 5-Aminolevuline Acid
Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
- To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells [ Time Frame: 1 day ]To determine if the use of 5-aminolevulinic acid (ALA) helps distinguish tumor cells from normal cells leading to an increase in the amount of tumor removal during neurosurgical resection of glioma.
- Determine the safety of 5-aminolevulinic acid (ALA) [ Time Frame: 14 days ]Determine the safety of a single dose of 5-aminolevulinic acid (ALA) administered preoperatively at a dose of 20 mg/kg body weight.
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): NCT01116661
|Contact: Ashley DeSilva, MPHemail@example.com|
|Contact: Jane Rabbitt, BSNfirstname.lastname@example.org|
|United States, California|
|UCSF Department of Neurosurgery||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Ashley DeSilva, MPH 415-353-2652 email@example.com|
|Contact: Jane Rabbitt, BSN 415-353-2652 firstname.lastname@example.org|
|Principal Investigator: Mitchel S Berger, MD|
|Sub-Investigator: Michael Prados, MD|
|Sub-Investigator: Susan S Chang, MD|
|Sub-Investigator: Nicholas Butowski, MD|
|Sub-Investigator: Jennifer Clarke, MD, MPH|
|Sub-Investigator: Jennie Taylor, MD|
|Principal Investigator:||Mitchel S Berger, MD||UCSF Department of Neurosurgery|