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Clinical Trial 20014

Cancer Type: Neurologic Oncology
Interventions:5-ALA

Study Type: Diagnostic
Phase of Study: N/A
Investigators:

  • Michael Vogelbaum

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

Summary

5-ALA and the Orbeye surgical microscope are U.S. Food and Drug Administration (FDA) approved products. For this study, however, the Orbeye microscope imaging system is being used with special filters to visualize 5-ALA fluorescence. The FDA currently permits the use of these filters. The purpose of this study is to collect medical information before, during, and after standard treatment in order to better understand how to make this type of procedure accessible to patients.

Objective

This study will assess the utility of a novel FDA-cleared exoscope surgical microscope equipped with a blue-light filter set to perform 5-ALA fluorescence-guided surgery for high-grade gliomas. The hypothesis is that visualization of 5-ALA fluorescence with the use of the exoscope during a standard clinically indicated glioma surgery will provide sufficient realtime visualization of residual tumor tissue and/or tumor-infiltrated brain tissue.

Inclusion Criteria

  • 18 to 75 years of age
  • Patients must have a suspected or biopsy-proven high-grade glioma (World Health Organization grade III or IV), new or recurrent
  • Indication for standard craniotomy for removal of a suspected or recurrent brain tumor
  • Karnofsky Performance Scale ≥60%
  • Patient signed written informed consent

  • Exclusion Criteria

    > Porphyria, hypersensitivity to porphyrins

  • Renal insufficiency: Creatinine > 2.0 mg/dl
  • Hepatic insufficiency: Bilirubin > 3 mg/dl GGT > 100 U/I  Other known malignancy (except basaliomas)
  • Women: Existing/planned pregnancy (to be checked by a pregnancy test if of childbearing age), Lactation or inadequate contraception (hormone-cycle regulation pill or condom)