Aminolevulinic acid hydrochloride for Ovarian cancer

Inclusion criteria

• {"criterion_text":"- Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial\n- Female\n- Age ≥ 18 years\n- Confirmed or suspected ovarian cancer or ovarian cancer recurrence\n- 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 criteria

• {"criterion_text":"- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial\n- Known history of hypersensitivity to porphyrins\n- Known secondary diagnoses that present a risk when using the IMP, in particular acute and chronic porphyria\n- Restricted kidney function (GFR < 50 ml/min)\n- Restricted liver function (bilirubin / AST/ALT > 3x ULN)\n- 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\n- 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\n- Known or persistent abuse of medication, drugs or alcohol\n- Current (positive pregnancy test, e.g. beta-hCG test in serum) or planned pregnancy or nursing women\n- Fertility-preserving surgical therapy\n- Presence of another type of cancer in the final histology\n- Preoperative classification of the patient as inoperable\n- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure"}

Primary endpoints

• {"endpoint_text":"- Percentage of patients with at least one 5-ALA positive and histologically positive ovarian cancer tumour manifestation that was not scheduled for resection based on the surgical plan established under standard conditions (normal light and palpation).","definition_or_measurement_approach":"Measure percentage of patients with at least one lesion that is 5-ALA positive and histologically confirmed as ovarian cancer, where that lesion was not scheduled for resection according to the preoperative surgical plan (comparison of intraoperative 5-ALA findings vs planned resections; histological confirmation of lesions)."}

Secondary endpoints

• {"endpoint_text":"- Assessment of active-substance-specific adverse reactions and serious adverse reactions of CTCAE grades 3, 4, and 5","definition_or_measurement_approach":"Adverse reactions graded per CTCAE; collection and assessment of active-substance-specific adverse events and serious adverse events of CTCAE grades 3–5."}
• {"endpoint_text":"- Perioperative morbidity (30 days); Comparison with historical data on perioperative morbidity at the study site applying the Memorial Sloan Kettering Cancer Center (MSKCC) Surgical Secondary Events (SSE) system","definition_or_measurement_approach":"Perioperative morbidity within 30 days post-surgery assessed and compared with historical site data using the MSKCC SSE system."}
• {"endpoint_text":"- Proportion of 5-ALA positive and histologically positive lesions out of all 5-ALA positive lesions","definition_or_measurement_approach":"Proportion = (number of lesions both 5-ALA positive and histologically positive) / (number of all 5-ALA positive lesions)."}
• {"endpoint_text":"- Proportion of 5-ALA positive and histologically positive lesions out of all histologically positive lesions","definition_or_measurement_approach":"Proportion = (number of lesions both 5-ALA positive and histologically positive) / (number of all histologically positive lesions)."}
• {"endpoint_text":"- Proportion of patients in whom all 5-ALA positive lesions are histologically negative","definition_or_measurement_approach":"Proportion of patients for whom every lesion that was 5-ALA positive proved histologically negative."}
• {"endpoint_text":"- Proportion of 5-ALA positive but histologically negative lesions among all 5-ALA positive lesions only","definition_or_measurement_approach":"Proportion = (number of lesions 5-ALA positive but histologically negative) / (number of all 5-ALA positive lesions)."}
• {"endpoint_text":"- PCI change by considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations","definition_or_measurement_approach":"Change in Peritoneal Cancer Index (PCI) when additionally resected 5-ALA positive and histologically confirmed tumour manifestations are considered."}
• {"endpoint_text":"- Change of FIGO classification considering additionally resected 5-ALA positive and histologically confirmed ovarian cancer tumour manifestations","definition_or_measurement_approach":"Change in FIGO stage/classification when additionally resected 5-ALA positive and histologically confirmed tumour manifestations are considered."}

Germany

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

615

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"photonamic GmbH & Co. KG (IMP)","duties_or_roles":"Source of monetary support (listed in sourceOfMonetarySupport)","organisation_type":""}
• {"country":"","full_name":"Kommission für Klinische Studien, Rheinische Friedrich-Wilhelms-Universität Bonn","duties_or_roles":"Source of monetary support (listed in sourceOfMonetarySupport)","organisation_type":""}