Clinical Studies Search

Protocol Summary


Protocol No.
PSHCI-16-018
Prinicipal Investigator
Zacharia, Brad
Phase
Phase II
Age Group
Adult
Scope
National
Secondary Protocol No.
CGH9152015
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
Objective
Primary Objectives
To determine the patient safety profile of both oral 5-ALA as well as use of the fluorescence operative microscope including the incidence of surgically-related neurological deficits in a multicenter study.
To determine whether Gliolan-induced PPIX fluorescence correlates with malignant tumor histopathology (in at least 3 serial biopsies in the fluorescent region of the tumor resection).
Secondary Objectives
To determine the extent of resection (EOR) on postoperative MRI by subtracting the postoperative volume of residual enhancing tumor from the preoperative initial volume of enhancing tumor.
To correlate the quantity or appearance of PPIX-containing extracellular microvesicles in blood with the initial tumor volume prior to resection.

To correlate PPIX and other microvesicles as a correlate of tumor MRI recurrence. These microvesicles will be evaluated at serial time points prior to and after surgery until MRI radiographic tumor progression by the RANO response criteria. Microvesicle evaluations will include PPIX, EGFRvIII, IDH1/2 and their mutations and others in tissue at time of surgery and in blood derived microparticles of tumor origin.
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center