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

Recruiting Phase 3 Interventional Study
Ovarian Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
170 (estimated)
Sponsor
NX Development Corp · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary diagnosis or high clinical suspicion of primary epithelial ovarian cancer, b. suspected epithelial, peritoneal, or fallopian tube cancer…
Contacts

Michael Giammona

512-348-3885

mgiammona@nxdevcorp.com

CONTACT

Ron Mims

505-681-3537

rmims@nxdevcorp.com

CONTACT