Ovarian CancerPhase 3NCT05804370
Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
A Phase 3 study testing Gleolan in people with Ovarian Cancer, run by NX Development Corp at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Gleolan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 11 sitesUnited States
- Study dates
- 30 May 2024to May 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 10 recruiting
- Completed
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
Nancy Tait Research Coordinator, 410-328-3546, ntait@umm.edu
Dana Roque, MD
- Recruiting
CAMC Institute for Academic Medicine - Cancer Research Center
Charleston, West Virginia, 25304
Susan Smith - Research Coordinator, 304-388-9940, Susan.R.Smith@vandaliahealth.org
Stephen Bush, MD
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Jackie Ludwig Research Coordinator, 216-390-2492, ludwigj@ccf.org
Johanna Kelley, MD
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
Genessis Ruiz - Research Coordinator, 904-495-3200, Ruiz.Genessis@mayo.edu
Matthew Robertson III, MD
- Not yet recruiting
WVU Cancer Institute
Morgantown, West Virginia, 26506
Ella Betler, 304-293-4274, eibetler@hsc.wvu.edu
Kritsy Ward, MD
- Recruiting
Mount Sinai
New York, New York, 10128
Neha Kumarley Research Coordinator, (212) 241-6500, neha.kumarley@mssm.edu
Stephanie Blank, MD
- Recruiting
Riverside Health
Newport News, Virginia, 23606
Meagan Gualtiere, BSN, RN, ACRP-CP, 757-534-5671, meagan.gualtiere@rivhs.com
William Irvin, MD
- Recruiting
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Courtney M. Nelson Clinical Research Coordinator, (480) 342-2000, nelson.courtney4@mayo.edu
Kristina Butler, MD
- Recruiting
Mayo Clinic Methodist Campus
Rochester, Minnesota, 55905
Annie Erickson Research Coordinator, (507) 422-3902, Erickson.Andrea@mayo.edu
Amanika Kumar, MD
- Recruiting
WellSpan Health
York, Pennsylvania, 17403
Nicole Imamovic Research Coordinator, 717-741-8019, nimamovic@wellspan.org
Eav Lim, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Gleolan
- Keywords
- ALA, Fluorescence guided surgery, Gleolan, Ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GleolanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients Receiving Gleolan | Experimental | All patients in this arm will receive Gleolan and undergo intraoperative imaging Receives: Drug: Gleolan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Positive Predictive Value (PPV) of Gleolan-induced FL among biopsies obtained from each study participant following SoC debulking surgery.
Measured: Surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start30 May 2024
- Primary completionSep 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NX Development Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristina Butler, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804370
- Sponsor's protocol ID
- NXDC-OVA-302
- Status last verified
- Jul 2026
- First submitted
- 27 Mar 2023
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05804370
- Acronym / sponsor ID
- NXDC-OVA-302
- Conditions
- Ovarian Cancer
- Keywords
- ALA, Fluorescence guided surgery, Gleolan, Ovarian cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- NX Development CorpIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving Gleolan | Experimental | Drug: GleolanAll patients in this arm will receive Gleolan and undergo intraoperative imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GleolanGleolan 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. | Drug | Patients Receiving Gleolan |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristina Butler, MD principal investigator
Mayo Clinic
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gleolan in people with Ovarian Cancer, run by NX Development Corp at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Giammona (512-348-3885, mgiammona@nxdevcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the clinical usefulness of Gleolan to detect epithelial ovarian cancer tissue not detected during SoC debulking surgery. (time frame: Surgery (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.