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5-Aminolevulinic Acid (5-ALA) for Intraoperative Imaging in Patients with Ovarian Cancer – a Single Center Feasibility Study (ILLUMINATE)
EU CTIS ID: 2024-510614-33-00
What this study is testing
To evaluate the efficacy of intraoperative imaging using 5-ALA to detect ovarian cancer tumour manifestations that would not have been identified as such by normal light and palpation and would not have been scheduled for resection.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
- Female
- Age ≥ 18 years
- Confirmed or suspected ovarian cancer or ovarian cancer recurrence
- Planned surgical treatment by staging or debulking laparotomy at the Department of Gynecology and Gynecologic Oncology at the University Hospital Bonn. Interval debulking operations after previous neoadjuvant chemotherapy are also included.
You likely can't join if
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Known history of hypersensitivity to porphyrins
- Known secondary diagnoses that present a risk when using the IMP, in particular acute and chronic porphyria
- Restricted kidney function (GFR < 50 ml/min)
- Restricted liver function (bilirubin / AST/ALT > 3x ULN)
- Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
See the full eligibility criteria
- Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
- Female
- Age ≥ 18 years
- Confirmed or suspected ovarian cancer or ovarian cancer recurrence
- Planned surgical treatment by staging or debulking laparotomy at the Department of Gynecology and Gynecologic Oncology at the University Hospital Bonn. Interval debulking operations after previous neoadjuvant chemotherapy are also included.
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- Known history of hypersensitivity to porphyrins
- Known secondary diagnoses that present a risk when using the IMP, in particular acute and chronic porphyria
- Restricted kidney function (GFR < 50 ml/min)
- Restricted liver function (bilirubin / AST/ALT > 3x ULN)
- Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
- Simultaneous participation in another surgical clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days after last IMP intake in that clinical trial
- Known or persistent abuse of medication, drugs or alcohol
- Current (positive pregnancy test, e.g. beta-hCG test in serum) or planned pregnancy or nursing women
- Fertility-preserving surgical therapy
- Presence of another type of cancer in the final histology
- Preoperative classification of the patient as inoperable
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
The study team makes the final eligibility decision.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.