Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer
About This Trial
This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery. The study is planned to run for about 18 months with individual study participation lasting about two (2) weeks.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Gleolan
Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength \[λ\] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light.