Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05804370
PHASE3

Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)

Sponsor: NX Development Corp

View on ClinicalTrials.gov

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

DRUG

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