Trials / Withdrawn
WithdrawnNCT01445691
More Complete Removal of Malignant Brain Tumors by Fluorescence-Guided Surgery
A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Constantinos Hadjipanayis · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and utility of 5-aminolevulinic acid (ALA) for identifying your tumor during surgery. 5-ALA is not FDA approved at this time. When the investigators remove the tumor from your brain, it is important that they remove all of the tumor and not remove parts of normal brain. Sometimes this can be difficult because the tumor can look like normal brain. In some brain tumors, 5-ALA can make the tumors glow red under blue light. This may make it easier for your doctor to take out all of the tumor from your brain. The purpose of this study is to: * Make sure that 5-ALA helps the doctor remove more of the tumor. * Make sure 5-ALA does not cause any side effects. If you do not want to participate in this study, your doctor(s) will still do their best to remove all of the tumor in your brain. Whether or not you join this study will not change your treatment for your brain tumor.
Conditions
- Benign Neoplasms, Brain
- Brain Cancer
- Brain Neoplasms, Benign
- Brain Neoplasms, Malignant
- Brain Tumor, Primary
- Brain Tumor, Recurrent
- Brain Tumors
- Intracranial Neoplasms
- Neoplasms, Brain
- Neoplasms, Intracranial
- Primary Brain Neoplasms
- Primary Malignant Brain Neoplasms
- Primary Malignant Brain Tumors
- Gliomas
- Glioblastoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 5-ALA (Gliolan) | 20 mg/kg administered once 3-5 hours prior to surgery |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2016-09-01
- Completion
- 2016-09-01
- First posted
- 2011-10-04
- Last updated
- 2016-05-17
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01445691. Inclusion in this directory is not an endorsement.