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New treatment option for Ovarian Cancer
Official title Gleolan for Visualization of Newly Diagnosed or Recurrent Ovarian Cancer (OVA-302)
ClinicalTrials.gov ID: NCT05804370
What this study is testing
What is Gleolan?
Gleolan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 18 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 1. Study will be limited to patients with the following diagnoses who plan to undergo surgical cytoreduction or interval debulking: a. primary...
- Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in
You likely can't join if
- 6 and 9.
- A pre-operative magnetic resonance image (MRI), positron emission tomography (PET), or computed tomography (CT) ≤ 30 days of study enrollment...
- 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): \ 60 mL/min/1.73 m2 for...
- The study subject t must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written...
See the full eligibility 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...
- Note: participants with a diagnosis of (a) or (b) may be treatment-naïve or have received neoadjuvant therapy, as clarified in
- 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...
- 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): \ 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...
- 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:
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Annapolis, Maryland, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- York, Pennsylvania, United States
- Newport News, Virginia, United States
- Charleston, West Virginia, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Annapolis, Maryland, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; New York, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.