Actively Recruiting
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
Led by NX Development Corp · Updated on 2025-10-01
170
Participants Needed
6
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Diagnosed with or strongly suspected of having primary epithelial ovarian cancer, suspected epithelial, peritoneal, or fallopian tube cancer, or recurrent epithelial ovarian cancer
- Planned to undergo surgical cytoreduction or interval debulking
- Recent (within 30 days) MRI, PET, or CT showing suspected tumor or recurrence requiring surgery
- Normal organ and bone marrow function, suitable for surgery per standard care
- Bilirubin, AST, ALT within defined normal limits; creatinine normal or creatinine clearance above 60 mL/min/1.73 m2
- Able to understand and willing to sign informed consent
- Women of childbearing potential agree to use effective contraception for at least 42 days after Gleolan administration
You will not qualify if you...
- Scheduled for laparoscopy when laparotomy/debulking is unlikely
- Known allergy to aminolevulenic acid or porphyrins
- Have acute or chronic porphyria
- Have uncontrolled illnesses like active infection, heart failure, unstable angina, arrhythmia, or psychiatric illness
- Received chemotherapy, tumor resection, or radiation within 21 days before surgery
- Social or medical issues limiting study compliance
- Pregnant or planning pregnancy during study
- Participated in another investigational trial within 21 days before or after Gleolan
- Using other phototoxic substances or topical ALA within 24 hours perioperatively
- Unwilling to sign consent or attend follow-up visits
- Any condition making them unsuitable as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Terminated
3
University of Maryland
Baltimore, Maryland, United States, 21201
Actively Recruiting
4
Mayo Clinic Methodist Campus
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Mount Sinai
New York, New York, United States, 10128
Actively Recruiting
6
WellSpan Health
York, Pennsylvania, United States, 17403
Actively Recruiting
Research Team
K
Kristina Hadley, MSN, RN
CONTACT
R
Ron Mims
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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