Study Overview

This Phase 3 study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan® (aminolevulinic acid hydrochloride, also referred to as ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real-time detection and visualization of de novo or recurrent epithelial ovarian cancer during tumor debulking. 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. This phenomenon provides the surgeon with real-time fluorescence (FL) visualization of malignant tissue during cancer resection surgery, which would otherwise not be readily visible to the naked eye. Patients pending resection for suspected epithelial ovarian cancer (Stage I-IV) will sign an informed consent and will be screened to assess study eligibility. Ovarian cancer patients with newly diagnosed disease and those with recurrent disease deemed medically eligible for tumor debulking surgery will be considered for participation. Study participants who are either treatment naïve or have received adjuvant therapy and/or interval debulking and allowed a minimum 21-day waiting period since last treatment are eligible for enrollment. Study participants will be evaluated within 48 hours post-procedure and 2 weeks post-procedure for study safety assessment.