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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
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
May 30, 2024
Primary Completion Date
January 1, 2027
Completion Date
May 1, 2027
Last Updated
October 1, 2025
170
ESTIMATED participants
Gleolan
DRUG
Lead Sponsor
NX Development Corp
NCT04550494
NCT05039801
Data Source & Attribution
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