Ovarian cancer Ovarian cancer, neo-adjuvant chemotherapy, interval debulking surgery
Conditions
Interventions
Administration of ALAGLIO (5-aminolevulinic acid) as a photodynamic diagnostic agent and implementation of photodynamic diagnosis during surgery
Administration, Oral
Sponsors
Yamaguchi Ken
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older with ovarian cancer who are candidates for neoadjuvant chemotherapy are eligible for diagnostic laparoscopy with tumor tissue sampling before treatment and are candidates for interval debulking surgery
Exclusion criteria
Exclusion criteria: 1. Patients with a history of hypersensitivity to porphyrin derivatives 2. Patients with porphyria 3. Patients taking medications known to cause photosensitivity: tetracycline antibiotics, sulfonamide preparations, new quinolone antibacterial agents, hypericin (St. John's Wort extract), etc., and patients taking foods containing St. John's Wort 4. Pregnant women, nursing mothers, and women who may be pregnant 5. Patients with clinical laboratory values meeting the following criteria (serum creatinine: 1.5 times or more the upper limit of normal, aspartate aminotransferase (AST): 3 times or more the upper limit of normal, alanine aminotransferase (ALT): 3 times or more the upper limit of normal, serum bilirubin: 1.5 times or more the upper limit of normal) 6. Other patients deemed inappropriate as research subjects by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic sensitivity of 5ALA-PDD for ovarian cancer lesions during interval debulking surgery using histopathological diagnosis as the gold standard | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Impact on surgical parameters (blood loss, operating time) 2. Complete resection rate and optimal surgery achievement rate 3. Utility and diagnostic accuracy of 5ALA-PDD for ovarian cancer during diagnostic laparoscopy or laparotomy before neoadjuvant chemotherapy 4. Surgeon's evaluation of utility 5. Adverse event rate 6. Comparison of diagnostic accuracy before and after neoadjuvant chemotherapy 7. Analysis of diagnostic accuracy by tumor location 8. Correlation analysis between fluorescence intensity and pathological findings 9. Correlation analysis between imaging studies and 5ALA-PDD | — |
Contacts
Public ContactYusuke Matoba
Hiroshima University Hospital
Outcome results
None listed