5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02632370|
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : February 25, 2019
|Condition or disease||Intervention/treatment|
|Malignant Gliomas||Drug: Gliolan® Procedure: Fluorescence-Guided Surgery|
- To determine whether Gliolan® (5-ALA)-induced PPIX fluorescence correlates with malignant tumor histopathology (in a minimum of 3-5 serial biopsies taken from the red fluorescent region of tissue resection).
- To determine the patient safety profile of both oral Gliolan® (5-ALA), as well as use of the fluorescence operative microscope. These will include use of commonly accepted toxicity measures as well as recording surgically-related neurological deficits within the six weeks after surgery.
- To determine functionality and performance reliability of the blue light excitation microscope platforms (Zeiss Pentero, Leica OH4, Leica OH6 and others).
- To correlate PPIX-containing extracellular microvesicles recovered from blood (at multiple time points prior to and following tumor resection) with the pre-operative MRI tumor volume.
- To characterize the presence and longitudinal changes in microvesicle biomarkers recovered from blood evaluating EGFRvIII, IDH1/2 wt and mutations and others. These microvesicular blood genes will be identified and correlated with the same microvesicular genes identified in tissue at the time of surgery.
|Study Type :||Observational|
|Actual Enrollment :||69 participants|
|Official Title:||A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients With Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials. The formulation contains 1.5 g 5-aminolevulinic acid hydrochloride corresponding to 1.17 g of 5-aminolevulinic acid. The oral solution is intended for single (partial) use.
single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively
Other Name: 5-ALA
Procedure: Fluorescence-Guided Surgery
performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.
Other Name: FGS
- Incidence of diagnostic tissue presence [ Time Frame: 6 weeks ]Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.
- Presence of malignant glioma tumor cells [ Time Frame: 6 weeks ]Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.
- WHO tumor type with grading [ Time Frame: 6 weeks ]Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.
- Ki-67 proliferation index [ Time Frame: 6 weeks ]Ki-67 is a prognostic marker for cancer
- Karnofsky Performance Scale [ Time Frame: 6 weeks ]Scale from 0-100, function from low to high, with 100 being normal
Biospecimen Retention: Samples With DNA
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): NCT02632370
|United States, District of Columbia|
|George Washington University|
|Washington, District of Columbia, United States, 20037|
|United States, Florida|
|Delray Medical Center|
|Delray Beach, Florida, United States, 33484|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Idaho|
|Saint Alphonsus Regional Medical Center|
|Boise, Idaho, United States, 83706|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, Minnesota|
|CentraCare St. Cloud Hospital|
|Saint Cloud, Minnesota, United States, 56303|
|United States, Missouri|
|St. Luke's Marion Bloch Neuroscience Institute|
|Kansas City, Missouri, United States, 64111|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, New Mexico|
|University of New Mexico School of Medicine, Department of Neurosurgery|
|Albuquerque, New Mexico, United States, 87131|
|United States, New York|
|Mount Sinai Beth Israel|
|New York, New York, United States, 10003|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|St. Luke's University Health Network|
|Bethlehem, Pennsylvania, United States, 18015|
|Penn State- Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Allegheny General Hospital|
|Pittsburgh, Pennsylvania, United States, 15212|
|United States, Utah|
|Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Bob Carter, MD, PhD||Massachusetts General Hospital|