Glow-in-the-Dark dye could help surgeons spot hidden ovarian cancer
NCT ID NCT05804370
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Epithelial fallopian tube cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
10 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGCharleston, West Virginia, 25304, United States
-
Luminis Health Anne Arundel Medical Center
COMPLETEDAnnapolis, Maryland, 21401, United States
-
Mayo Clinic Arizona
RECRUITINGPhoenix, Arizona, 85054, United States
-
Mayo Clinic Florida
RECRUITINGJacksonville, Florida, 32224, United States
-
Mayo Clinic Methodist Campus
RECRUITINGRochester, Minnesota, 55905, United States
-
Mount Sinai
RECRUITINGNew York, New York, 10128, United States
-
Riverside Health
RECRUITINGNewport News, Virginia, 23606, United States
-
The Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
-
University of Maryland
RECRUITINGBaltimore, Maryland, 21201, United States
-
WVU Cancer Institute
NOT_YET_RECRUITINGMorgantown, West Virginia, 26506, United States
-
WellSpan Health
RECRUITINGYork, Pennsylvania, 17403, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Mapping the DNA test that decides who gets PARP inhibitors
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?