A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
NCT01351519 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2016-03-17
Summary
In this study subjects will be administered a single oral dose of Aminolevulinic Acid (ALA) prior to surgical resection of their brain tumor. The ALA ultimately causes brain tumor tissue to fluoresce or light up under ultraviolet light. During surgery an ultraviolet light in the microscope chain will be turned on. The tumor tissue will fluoresce bright pink allowing the surgeon to more easily differentiate tumor tissue from normal brain tissue. The aim of the study is to determine whether ALA and fluorescent visualization of tumor tissue improves the surgeon's ability to completely resect or remove the brain tumor.
Conditions
- Malignant Glioma
- Glioma
- Glioblastoma
- Glioblastoma Multiforme
- Astrocytoma
Interventions
- DRUG
-
Aminolevulinic Acid
Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
Sponsors & Collaborators
-
MultiCare Health System Research Institute
lead OTHER
Principal Investigators
-
William Morris, MD · MultiCare Health System
-
Richard Shine, PharmD, BCPS · MultiCare Health System Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-05-31
- Primary Completion
- 2015-01-31
- Completion
- 2015-01-31
Countries
- United States
Study Locations
More Related Trials
-
Aminolevulinic Acid in Visualizing a Tumor During Surgery in Patients With Glioblastoma Multiforme
NCT01575275 ·Status: TERMINATED ·Phase: PHASE2
-
Safety Study of Aminolevulinic Acid (ALA) to Improve Visibility of Brain Tumors During Surgery
NCT00961090 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors
NCT00977795 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Safety Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Tumors of the Brain
NCT01116661 ·Status: TERMINATED ·Phase: PHASE2
-
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
NCT00241670 ·Status: COMPLETED ·Phase: PHASE3
-
ALA-induced PpIX Fluorescence During Brain Tumor Resection
NCT02191488 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study of the Specificity and Sensitivity of 5- Aminolevulinic Acid (ALA) Fluorescence in Malignant Brain Tumors
NCT01128218 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid(5-ALA)
NCT06417281 ·Status: COMPLETED ·Phase: PHASE3
-
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas
NCT05850377 ·Status: NOT_YET_RECRUITING
-
5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor
NCT02632370 ·Status: COMPLETED
-
Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma
NCT00752323 ·Status: COMPLETED ·Phase: PHASE2
-
Fluorescence Guided Resection of Brain Tumors
NCT00870779 ·Status: COMPLETED ·Phase: PHASE1
-
Phase III Clinical Trial Evaluating the Resection Efficacy of 5-Aminolevulinic Acid Hydrochloride (5-ALA HCl) Fluorescence-Guided Microsurgery Versus Conventional White Light Microsurgery in Patients With Malignant Glioma (WHO Grade 3/4)
NCT06160492 ·Status: RECRUITING ·Phase: PHASE3
-
Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas
NCT04055688 ·Status: COMPLETED
-
A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas
NCT04390802 ·Status: UNKNOWN
-
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
NCT02755142 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma
NCT01310868 ·Status: COMPLETED ·Phase: PHASE2
-
Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
NCT01167322 ·Status: COMPLETED ·Phase: PHASE3
-
Methotrexate Infusion Into the Fourth Ventricle in Children With Malignant Fourth Ventricular Brain Tumors: A Pilot Study
NCT01737671 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Phase I/II Study of the Photon Radiosurgery System
NCT00179907 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Sirolimus in Treating Patients With Glioblastoma Multiforme
NCT00047073 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Methotrexate Infusion Into Fourth Ventricle in Children With Recurrent Malignant Fourth Ventricular Brain Tumors
NCT02458339 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate 5-ALA Combined With CV01 Delivery of Ultrasound in Recurrent High Grade Glioma
NCT05362409 ·Status: COMPLETED ·Phase: PHASE1
-
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
NCT00006119 ·Status: COMPLETED ·Phase: PHASE2
-
Vorinostat and Concurrent Whole Brain Radiotherapy for Brain Metastasis
NCT01600742 ·Status: TERMINATED ·Phase: PHASE2