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Development of a novel diagnostic method for ovarian cancer lesions using 5-aminolevulinic acid

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	ovarian, fallopian tube and peritoneal cancer
Date of first enrollment	17/03/2025
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	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 surgery is performed. Immediately after laparotomy, peritoneal dissemination lesions is observed, dividing the abdominal cavity into seven regions (omentum, subdiaphragmatic area, right paracolic gutter, left paracolic gutter, vesicouterine pouch, pouch of Douglas, and small intestinal mesentery). Observations under white light (macroscopic findings) and blue light (fluorescent findings) are recorded for each region. If multiple lesions are present within a region and their findings under white light and blue light differ, additional descriptions for each lesion will be provided. Observations under blue light will be conducted both immediately after laparotomy and just before specimen resection. These evaluations under white and blue light will follow a three-point scale: White light (1. Clearly visible lesion, 2. Possible lesion, 3. No lesion), Blue light (1. Clearly visible fluorescence, 2. Possible fluorescence, 3. No fluorescence). Ultimately, findings are categorized as either lesion present (white light 1 or 2, blue light 1 or 2) or no lesion (white light 3, blue light 3). When a lesion is deemed present, the tumor diameter are also measured. These evaluations are independently performed by two specialists in gynecologic oncology or trainees in gynecologic oncology. The time of blue-light observation and the duration of each observation are recorded. To enable reevaluation of the criteria, intraoperative findings are documented with photographs. Tumor resection proceed in the usual manner for areas judged to have lesions under white light or blue light by at least one evaluator. Given that red fluorescence induced by ALA-PDD is expected to diminish over time during surgery, ALA-PDD findings just prior to resection are not used to define the resection area. For areas deemed free of lesions, random peritoneal biopsies are performed within the scope of minimal patient burden. All resected specimens undergo pathological and histological evaluation to correlate macroscopic findings and fluorescence observations. If peritoneal dissemination lesions are detected in random peritoneal biopsies, postoperative treatment are determined based on the pathological results.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Female
Include 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.
Exclude 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.