Using Gleolan to improve visualization of ovarian cancer during surgery

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 study is testing if a special dye called Gleolan can help doctors see ovarian cancer tumors better during surgery to improve patient outcomes.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: NX Development Corp (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Phoenix, Arizona and 5 other locations)
• Trial ID: NCT05804370 on ClinicalTrials.gov

What this trial studies

This Phase 3 study aims to evaluate the safety and effectiveness of Gleolan for real-time detection and visualization of epithelial ovarian cancer tumors during debulking surgery. The study consists of two training phases to optimize workflow and data collection, followed by a pivotal randomized phase to assess the clinical usefulness of Gleolan. Participants will receive Gleolan before surgery, and their tumors will be assessed using blue light imaging to enhance surgical outcomes. The study is expected to last about 18 months, with individual participation lasting approximately two weeks.

Who should consider this trial

Good fit: Ideal candidates include females aged 18 and older with a diagnosis of primary or recurrent epithelial ovarian cancer who are scheduled for surgical debulking.

Not a fit: Patients with non-epithelial ovarian cancer or those who are not surgical candidates may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved surgical outcomes and better detection of ovarian cancer tumors, potentially reducing recurrence rates.

How similar studies have performed: Other studies utilizing fluorescence-guided surgery have shown promising results, indicating potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Phoenix, Arizona and 5 other locations

• Mayo Clinic Arizona — Phoenix, Arizona, United States (Recruiting)
• Luminis Health Anne Arundel Medical Center — Annapolis, Maryland, United States (Terminated)
• University of Maryland — Baltimore, Maryland, United States (Recruiting)
• Mayo Clinic Methodist Campus — Rochester, Minnesota, United States (Recruiting)
• Mount Sinai — New York, New York, United States (Recruiting)
• WellSpan Health — York, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Kristina Butler, MD — Mayo Clinic
• Study coordinator: Kristina Hadley, MSN, RN

Conditions Ovarian Cancer; ALA; Fluorescence guided surgery; Gleolan; Ovarian cancer