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Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
Sponsor: NX Development Corp
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2024-05-30
Completion Date
2027-05
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (6)
Mayo Clinic Arizona
Phoenix, Arizona, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Mayo Clinic Methodist Campus
Rochester, Minnesota, United States
Mount Sinai
New York, New York, United States
WellSpan Health
York, Pennsylvania, United States