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Glow-in-the-Dark dye could help surgeons spot hidden ovarian cancer

NCT ID NCT05804370

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests a drug called Gleolan that makes ovarian cancer cells glow during surgery. The goal is to help surgeons find and remove tumors they might otherwise miss. About 170 women with suspected or recurrent ovarian cancer will take part. The study lasts about two weeks per person.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CAMC Institute for Academic Medicine - Cancer Research Center

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Luminis Health Anne Arundel Medical Center

    COMPLETED

    Annapolis, Maryland, 21401, United States

  • Mayo Clinic Arizona

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Methodist Campus

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10128, United States

  • Riverside Health

    RECRUITING

    Newport News, Virginia, 23606, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • WVU Cancer Institute

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

  • WellSpan Health

    RECRUITING

    York, Pennsylvania, 17403, United States

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