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

September 26, 2025 updated by: NX Development Corp

A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study will be conducted in the following phases:

  • Part A1 is an open-label training phase of the study to optimize workflow and collect data on the tumor-to-background ratio (TBR) of images of Gleolan-induced fluorescence (FL). Participants will receive Gleolan followed by blue light (BL) assessment and bulk tumor biopsy with imaging to establish TBR.
  • Part A2 is an open-label training phase of the study to optimize workflow and obtain data to optimize the sample size estimate for Part B. Participants in Part A2 receive Gleolan and undergo Standard of Care (SoC) ovarian cancer debulking, followed by BL assessment and biopsy collection.
  • Part B is the randomized pivotal portion of the study for the evaluation of safety, diagnostic performance, and clinical usefulness of Gleolan for the real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Arizona
        • Contact:
        • Principal Investigator:
          • Kristina Butler, MD
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Terminated
        • Luminis Health Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland
        • Principal Investigator:
          • Dana Roque, MD
        • Contact:
          • Nancy Tait Research Coordinator
          • Phone Number: 410-328-3546
          • Email: ntait@umm.edu
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Methodist Campus
        • Principal Investigator:
          • Amanika Kumar, MD
        • Contact:
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • Mount Sinai
        • Principal Investigator:
          • Stephanie Blank, MD
        • Contact:
    • Pennsylvania
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health
        • Contact:
        • Principal Investigator:
          • Eav Lim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, 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.

  2. 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.
  3. Females (only) age ≥ 18 years.
  4. Study participants must have normal organ and bone marrow function and be appropriate surgical candidates per site SoC.

  5. 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

  6. 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.
  7. 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.

Exclusion Criteria:

  1. Patient is to undergo laparoscopy and their surgeon believes it is unlikely that laparotomy/debulking will occur.
  2. Hypersensitivity to aminolevulenic acid (ALA) or porphyrins.
  3. Acute or chronic types of porphyria.
  4. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
  5. Patient has had chemotherapy, tumor resection or radiation treatment within 21 days prior to surgery.
  6. 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.
  7. Women who are pregnant or plan to become pregnant during study participation.
  8. Simultaneous participation in another investigational treatment trial in the 21 days directly preceding or after study drug administration.
  9. 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.
  10. Unwillingness by study participant to sign consent or return for subsequent visits following surgery.
  11. Any condition that in the opinion of the Investigator would exclude the study participant as a viable candidate for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Receiving Gleolan
All patients in this arm will receive Gleolan and undergo intraoperative imaging
Drug: Gleolan
Gleolan is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The oral provision of Gleolan leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (wavelength [λ] = 375 - 450 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.
Time Frame: Surgery (Day 1)
Percentage of participants with at least one suspected ovarian cancer lesion (including lymph nodes) where Gleolan-induced FL is confirmed by central histopathology (Standard of Truth) to be tumor that was not detected during SoC debulking, among all participants who meet the eligibility criteria for the study and receive any amount of Gleolan.
Surgery (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Surgery (Day 1)
Positive Predictive Value (PPV) of Gleolan-induced FL among biopsies obtained from each study participant following SoC debulking surgery.
Surgery (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NX Development Corp

Investigators

  • Principal Investigator: Kristina Butler, MD, Mayo Clinic
  • Principal Investigator: John McBroom, MD, Luminis Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXDC-OVA-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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