5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor
Status:
Completed
Trial end date:
2018-12-31
Target enrollment:
Participant gender:
Summary
In support of the US marketing application for 5-ALA, this single arm trial is being
conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly
diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as
an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with
malignant histopathology. The primary objective in this single arm study is to define the
positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at
the time of initial resection and first use of FGS by taking a biopsy of tissue presenting
with red fluorescence when observed during the course of resection of new or recurrent
malignant gliomas. The functionality and performance reliability of the blue light excitation
microscope platforms will be assessed.
Details
Lead Sponsor:
Constantinos Hadjipanayis
Collaborators:
Massachusetts General Hospital University of California, San Diego