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Gleolan for Ovarian Cancer

Phase 3
Recruiting
Led By Kristina Butler, MD
Research Sponsored by NX Development Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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, c. recurrent epithelial ovarian cancer.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up surgery (day 1)
Awards & highlights

Summary

This trial will test the safety and effectiveness of Gleolan for helping surgeons find ovarian cancer tumors during surgery. It will last about 18 months, with each participant involved for about two weeks.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects for Gleolan in this context aren't detailed here, common ones from similar procedures may include allergic reactions to the agent used for visualization, tissue irritation at the surgical site, and general risks associated with surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am diagnosed with or suspected to have ovarian, peritoneal, or fallopian tube cancer and plan to have surgery to remove it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surgery (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.
Secondary study objectives
To determine the biopsy-level PPV (i.e., diagnostic performance) of Gleolan for the real-time visualization of newly diagnosed or recurrent epithelial ovarian cancer during debulking surgery.

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT02075671
10%
Contact Dermatitis
10%
Post-Treatment Erythema
10%
Hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levulan and Blu-U Light
Vehicle and Blu-U Light
Vehicle Only

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients Receiving GleolanExperimental Treatment1 Intervention
All patients in this arm will receive Gleolan and undergo intraoperative imaging

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Who is running the clinical trial?

NX Development CorpLead Sponsor
3 Previous Clinical Trials
171 Total Patients Enrolled
Kristina Butler, MDPrincipal InvestigatorMayo Clinic
John McBroom, MDPrincipal InvestigatorLuminis Health
~113 spots leftby Jan 2026
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