ovarian, fallopian tube and peritoneal cancer Carcinoma, Ovarian Epithelial
Conditions
Interventions
Aminolevulinic acid hydrochloride is dissolved at 20 mg/kg in water and administered before the scheduled entry into the operating room. After entering the operating room, a standard ovarian cancer su
Sponsors
Yoneoka Yutaka
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Patients suspected clinically of having ovarian, fallopian tube, or peritoneal cancer who are undergoing surgery involving tissue sampling, or patients already diagnosed with these conditions undergoing surgical treatment. 2. Performance Status (ECOG) of 0 or 1. 3. The latest test results within 56 days prior to registration meet all of the following criteria 1) White blood cell count is 3,000/mm3 or more 2) Platelet count is 100,000/mm3 or more 3) AST is 100 IU/L or less, ALT is 100 IU/L or less 4) Total bilirubin is 2.0 g/dl or less 5) Serum creatinine is 1.5 g/dl or less 4. Written informed consent has been obtained from the patient for participation in this study.
Exclusion criteria
Exclusion criteria: 1. Difficulty in taking oral medications. 2. A history of photosensitivity or photodermatosis. 3. Hypersensitivity or a history of hypersensitivity to porphyrin-related substances. 4. Cases with a possibility of pregnancy, pregnant women, or breastfeeding women. 5. Other cases deemed unsuitable for participation in this study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of ALA-PDD for identifying peritoneal dissemination under white light and blue light are calculated using postoperative pathological diagnoses as the reference standard. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Tumor diameter for identifying peritoneal dissemination lesions using ALA-PDD 2) Concordance rate between intraoperative findings of ALA-PDD and findings at the time of resection 3) Inter-observer agreement rate for white light and ALA-PDD findings 4) Sensitivity and specificity of peritoneal dissemination lesion identification using white light and ALA-PDD, with pathological findings as the reference standard (limited to cases treated with preoperative chemotherapy) 5) Inter observer agreement rate for white light and ALA-PDD findings (limited to cases treated with preoperative chemotherapy) 6) Incidence of adverse events (adverse drug reactions) 7) Progression free survival | — |
Contacts
Public ContactYutaka Yoneoka
Shiga University of Medical Science
Outcome results
None listed