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

Ovarian Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05804370
Study type Interventional
Source NX Development Corp
Contact Kristina Hadley, MSN, RN
Phone 425-530-7040
Email khadley@nxdevcorp.com
Status Recruiting
Phase Phase 3
Start date May 30, 2024
Completion date May 2026
View Details
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