5-Aminolevulinic Acid (5-ALA) for Intraoperative Imaging in Patients with Ovarian Cancer – a Single Center Feasibility Study (ILLUMINATE)
Key facts
- Where
- Bonn, NémetországSee the site
- Phase
- 2. fázis
Where in Németország
- Universitaetsklinikum Bonn AöRBonn, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Trial code
- EU 2024-510614-33-00
- Record updated
- 2026. május 11.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Fertility-preserving surgical therapy; Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure; Known history of hypersensitivity to porphyrins; 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; Presence of another type of cancer in the final histology; Restricted kidney function (GFR < 50 ml/min); Restricted liver function (bilirubin / AST/ALT > 3x ULN); Current (positive pregnancy test, e.g. beta-hCG test in serum) or planned pregnancy or nursing women; Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial; Known secondary diagnoses that present a risk when using the IMP, in particular acute and chronic porphyria; Preoperative classification of the patient as inoperable.