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

NCT05804370 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NXDC-OVA-302
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 6

Brief Summary

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

Ovarian Cancer

Keywords

ALA; Fluorescence guided surgery; Gleolan; Ovarian cancer

Outcome Measures

Primary Outcomes (1)

• To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery.

  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 Outcomes (1)

• 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.

  Surgery (Day 1)

Study Arms (1)

Patients Receiving Gleolan

EXPERIMENTAL

All patients in this arm will receive Gleolan and undergo intraoperative imaging

Drug: Gleolan

Interventions

Gleolan DRUG

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.

Patients Receiving Gleolan

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NX Development Corp: lead

Study Sites (6)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

RECRUITING

Luminis Health Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

TERMINATED

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

Mayo Clinic Methodist Campus

Rochester, Minnesota, 55905, United States

RECRUITING

Mount Sinai

New York, New York, 10128, United States

RECRUITING

WellSpan Health

York, Pennsylvania, 17403, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kristina Butler, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• John McBroom, MD

  Luminis Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Hadley, MSN, RN

CONTACT

425-530-7040; khadley@nxdevcorp.com

Ron Mims

CONTACT

505-681-3537; rmims@nxdevcorp.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 7, 2023
• Study Start: May 30, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)