Gleolan for Ovarian Cancer

Overseen By Kristina Hadley, MSN, RN

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: NX Development Corp

Must not be taking: Phototoxic substances

Disqualifiers: Porphyria, Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

170 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain phototoxic substances (medications that make the skin sensitive to light) like St. John's wort and some antibiotics for 24 hours during the perioperative period (around the time of surgery). Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Research Team

Kristina A. Butler, M.D.

Principal Investigator

Mayo Clinic

John McBroom, MD

Principal Investigator

Luminis Health

Eligibility Criteria

This trial is for patients with a new or returning diagnosis of epithelial ovarian cancer who are scheduled for surgery to remove the tumor. It includes those who may be treatment-naïve or have had prior therapy, specifically targeting primary epithelial ovarian, peritoneal, or fallopian tube cancers.

Inclusion Criteria

I am diagnosed with or suspected to have ovarian, peritoneal, or fallopian tube cancer and plan to have surgery to remove it.

I may or may not have received initial treatment for my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Part A1 - Training

Open-label training phase to optimize workflow and collect data on tumor-to-background ratio using Gleolan-induced fluorescence

1 week

1 visit (in-person)

Part A2 - Training

Open-label training phase to optimize workflow and obtain data for sample size estimation for Part B

1 week

1 visit (in-person)

Part B - Randomized Pivotal

Evaluation of safety, diagnostic performance, and clinical usefulness of Gleolan for real-time detection and visualization during debulking surgery

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Gleolan

Trial Overview The study tests Gleolan's ability to help surgeons see and remove ovarian cancer tumors in real-time during debulking surgery. This Phase 3 trial will assess its safety, diagnostic accuracy, and clinical value over an approximate period of 18 months with two weeks of individual participation.

Participant Groups

Group I: Patients Receiving Gleolan Experimental Treatment 1 Intervention

All patients in this arm will receive Gleolan and undergo intraoperative imaging

Who Is Running the Clinical Trial?

NX Development Corp

Lead Sponsor

Trials

4

Recruited

330+