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.
The study will be conducted in the following phases: * Part A1 is an open-label training phase of the study to optimize workflow and collect data on the tumor-to-background ratio (TBR) of images of Gleolan-induced fluorescence (FL). Participants will receive Gleolan followed by blue light (BL) assessment and bulk tumor biopsy with imaging to establish TBR. * Part A2 is an open-label training phase of the study to optimize workflow and obtain data to optimize the sample size estimate for Part B. Participants in Part A2 receive Gleolan and undergo Standard of Care (SoC) ovarian cancer debulking, followed by BL assessment and biopsy collection. * Part B is the randomized pivotal portion of the study for the evaluation of safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
170
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.
Mayo Clinic Arizona
Phoenix, Arizona, United States
RECRUITINGLuminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
TERMINATEDUniversity of Maryland
Baltimore, Maryland, United States
To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.
Percentage of participants with at least one suspected ovarian cancer lesion (including lymph nodes) where Gleolan-induced FL is confirmed by central histopathology (Standard of Truth) to be tumor that was not detected during SoC debulking, among all participants who meet the eligibility criteria for the study and receive any amount of Gleolan.
Time frame: Surgery (Day 1)
To determine the biopsy-level PPV (i.e., diagnostic performance) of Gleolan for the real-time visualization of newly diagnosed or recurrent epithelial ovarian cancer during debulking surgery.
Positive Predictive Value (PPV) of Gleolan-induced FL among biopsies obtained from each study participant following SoC debulking surgery.
Time frame: Surgery (Day 1)
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Mayo Clinic Methodist Campus
Rochester, Minnesota, United States
RECRUITINGMount Sinai
New York, New York, United States
RECRUITINGWellSpan Health
York, Pennsylvania, United States
RECRUITING