SBI Pharmaceuticals Co., Ltd. (SBI) is a pharmaceutical authorization holder of the orally available 5-aminolevulinic acid (5-ALA) in Japan for visualization of glioma and bladder cancer. SBI provides 5-ALA as a research material and makes mutual collaborations with academic institutions. We examined four published studies of 5-ALA-FD (5-ALA fluorescence guided detection) conducted in Japan. 5-ALA was orally administrated at 20mg/kg body weight or 1g per patient at 2-4 hours before surgery or diagnosis. Bladder cancer: The presence of CIS (carcinoma in situ) affects recurrence of non-muscle-invasive bladder cancer. Additional CISs were detected and diagnosed only by 5-ALA-FD in 9 out of 60 patients and they were classified as high risk group. Peritoneal metastasis of gastric cancer: The addition of 5-ALA-FD to conventional laparoscopy enabled us to identify usually invisible peritoneal metastases in 5 of 24 patients with advanced gastric cancer. Pancreatic cancer: Peritoneal nodules suspected to be peritoneal metastases were observed under white light in 9 of 34 patients. The nodules in 4 of 9 patients showed fluorescence by 5-ALA-FD and were histopathologically diagnosed as metastases. Lung cancer: Fluorescence was confirmed in 14 of 14 PL1-PL3 patients and 10 of 24 PL0 patients. PL0 patients showed red fluorescence were preoperatively diagnosed as stage PL1. Accurate intraoperative diagnosis for visceral pleural invasion in lung cancer was performed by 5-ALA-FD. Four studies indicate that 5-ALA-FD is useful for distinction of tumors such as small lesions and contributes to selection of an appropriate therapy without a non-curative resection.

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Motowo Nakajima, "Current clinical studies on 5-ALA-FD (5-aminolevulinic acid mediated-fluorescence guided detection) in detection of lung, gastric, pancreatic, and bladder cancers in Japan (Conference Presentation)," Proc. SPIE 11070, 17th International Photodynamic Association World Congress, 1107020 (Presented at 17th International Photodynamic Association World Congress: June 30, 2019; Published: 14 August 2019); https://doi.org/10.1117/12.2527963.6069257677001.