Who is eligible for clinical trial NCT05804370?

Participants must meet protocol criteria for Ovarian Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05804370 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-13

Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302) (NCT05804370)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: NX Development Corp

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: Mayo Clinic Arizona — Phoenix, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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. Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in Exclusion Criteria 6 and 9.
A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment documenting a suspected tumor or suspected recurrence of tumor for which surgical debulking is indicated and has been planned.
Females (only) age ≥ 18 years.
Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC.
Study participant must have recording of each parameter as defined below: Bilirubin: Below upper limit of normal AST (SGOT): \< 2.5 X institutional upper limit of normal ALT (SGPT): \< 2.5 X institutional upper limit of normal Creatinine: Below upper limit of normal OR Creatinine clearance: \>60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and Spanish. Translation for non-English speaking participants will be provided as appropriate by institution, as required.
Women of childbearing potential must agree to use highly effective forms of contraception for at least 42 days after the one-time use of the Gleolan study drug.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur.
Hypersensitivity to aminolevulenic acid (ALA) or porphyrins.
Acute or chronic types of porphyria.
Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery.
Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI, PET, or CT.
Women who are pregnant or plan to become pregnant during study participation.
Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration.
Simultaneous use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.
Unwillingness by study participant to sign consent or return for subsequent visits following surgery.
Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (11 Sites)

Mayo Clinic Arizona — Phoenix, Arizona
Mayo Clinic Florida — Jacksonville, Florida
Luminis Health Anne Arundel Medical Center — Annapolis, Maryland
University of Maryland — Baltimore, Maryland
Mayo Clinic Methodist Campus — Rochester, Minnesota
Mount Sinai — New York, New York
The Cleveland Clinic Foundation — Cleveland, Ohio
WellSpan Health — York, Pennsylvania
Riverside Health — Newport News, Virginia
CAMC Institute for Academic Medicine - Cancer Research Center — Charleston, West Virginia
WVU Cancer Institute — Morgantown, West Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗