Letzte Aktualisierung: 06.05.2026
Eierstockkrebs (Ovarialkarzinom) [C56]
ILLUMINATE
Studieninformationen
5-Aminolevulinic Acid (5-ALA) for Intraoperative Imaging in Patients with Ovarian Can- cer - a Single Center Feasibility Study (ILLUMINATE)
Ziele
Primäres Prüfziel
To evaluate the efficacy of intraoperative imaging us-ing 5-ALA to detect ovarian cancer tumour manifes-tations that would not have been identified as such by normal light and palpation and would not have been scheduled for resection
Sekundäre Prüfziele für die Behandlungsarme:
To evaluate the application of intraoperative imaging using 5-ALA to detect ovarian cancer tumour mani-festations regarding: - Safety - Assessment of active-substance-specific ad-verse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5 - Perioperative morbidity (30 days); Comparison with historical data on perioperative morbidity at the study site applying the Memorial Sloan Ket-tering Cancer Center (MSKCC) Surgical Second-ary Events (SSE) system - Positive predictive value - Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions - Sensitivity - Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive le-sions - Patient-related false positive rate - Proportion of patients in whom all 5-ALA positive lesions are histologically negative - Lesion-related false positive rate - Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive le-sions only - Peritoneal Cancer Index (PCI) - PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovar-ian cancer tumour manifestations - International Federation of Gynecology and Ob-stetrics (FIGO) classification 2018 - Change of FIGO classification considering addi-tionally resected 5-ALA positive and histologi-cally confirmed ovarian cancer tumour manifes-tations
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Operative Therapie des Ovarialkarzinoms
Mutation
Patienten
Alter
Einschlusskriterien
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 De-partment of Gynecology and Gynecologic Oncology at the University Hos-pital Bonn. Interval debulking operations after previous neoadjuvant chem-otherapy are also included.
Ausschlusskriterien
Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial - 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) 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 - 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)
Therapie
Intervention
Substanz
| Prüfplancode | GYN-202301 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | - |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




