PDT

PDT Clinical Trials

Although a newly developed treatment like photodynamic therapy does not require Food and Drug Administration (FDA) approval before it can be used as a mainstream treatment, it must still undergo a series of clinical trials to ensure its safety and efficacy.

One such photodynamic clinical trial that is tentatively expected to begin in 2007 revolves around the testing of Etanidazole Derivative EF5. Etanidazole is a type of drug that serves to increase the effectiveness of radiation therapy; EF5 is a type of drug that is used to help plan cancer treatments by measuring oxygen levels found in tumor cells.

The objectives of the Etanidazole Derivative EF5 PDT clinical trial include:

  • Determination of the level of hypoxia (tissue oxygen deficiency) in patients suffering from pleural or peritoneal mesothelioma who are being treated with PDT. Hypoxia measurements are determined by observing Etanidazole Derivative EF5.
  • Determination of any/all toxic side effects of EF5.
  • Determination of the microvascular density of patients in the study.
  • Determination of the relationship between hypoxia levels, microvascular density and photosensitizer levels of patients participating in the study.
  • Determination of any correlation that exists between levels of hypoxia and photosensitizers with patients' clinical outcome.

Patients who are eligible for participation in this PDT clinical trial will receive Etanidazole Derivative EF5 intravenously over a one- to two-hour period. Peritoneal mesothelioma patients will undergo surgical resection 48 hours after EF5 treatment; pleural mesothelioma patients will undergo surgical resection 24 hours after EF5 treatment. Sectioned tumors receive a histopathological examination to determine EF5 binding and microvascular density through immunohistochemistry and fluorescent antibody techniques.

Conducted by the University of Pennsylvania, the study seeks approximately 80 mesothelioma patients over the age of 18, 50 of whom suffer from peritoneal mesothelioma and 30 of whom suffer from pleural mesothelioma.