Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
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ClinicalTrials.gov Identifier: NCT00961090 |
Recruitment Status :
Completed
First Posted : August 18, 2009
Last Update Posted : April 12, 2019
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Condition or disease | Intervention/treatment | Phase |
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Glioblastoma | Drug: Aminolevulinic Acid | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain. |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | April 22, 2015 |
Actual Study Completion Date : | April 23, 2015 |

Arm | Intervention/treatment |
---|---|
Single-Arm
Single-Arm All subjects received 20mg/kg of Aminolevulinic Acid diluted in 50cc of water, orally, approximately 3 hours prior to surgery.
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Drug: Aminolevulinic Acid
20 mg/kg mixed in 50cc water and taken orally 3 hours prior to surgery
Other Name: ALA |
- More complete resection of malignant brain tumors [ Time Frame: 3-7 days ]
- Safety of drug [ Time Frame: 1 month ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected primary brain tumor
- 18 years of age or more
- Normal marrow and organ function
- Eastern Cooperative Group performance status ≤ 2
- Women of childbearing potential must use adequate birth control
- Ability to understand and willingness to sign a written informed consent form
- Life expectancy not a consideration
Exclusion Criteria:
- Receiving any other investigational agents
- History of allergic reactions to ALA
- Personal or family history of porphyrias
- Liver disease in the past year
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Inability to undergo MRI with contrast

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): NCT00961090
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 |
Principal Investigator: | Matthew R Quigley, MD | The Guthrie Clinic |
Responsible Party: | Matthew R Quigley, administrator, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) |
ClinicalTrials.gov Identifier: | NCT00961090 |
Other Study ID Numbers: |
104974 |
First Posted: | August 18, 2009 Key Record Dates |
Last Update Posted: | April 12, 2019 |
Last Verified: | September 2015 |
Brain tumor glioma surgical resection ALA ultraviolet light |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |