Edogawa Hospital, which provides BNCT (Boron Neutron Capture Therapy) as a self-pay medical service, reports progress on Phase 2 (efficacy confirmation) of its specific clinical research on BNCT

Edogawa Hospital (Location: Edogawa-ku, Tokyo; Hospital Director: Shojiro Kato), a social welfare corporation, reports that it has confirmed favorable treatment progress, including tumor disappearance (Complete Response: CR), in cases of recurrent breast cancer and untreated primary breast cancer during its specific clinical research Phase 2 (efficacy confirmation stage). BNCT is a type of radiation therapy that utilizes boron compounds taken up by cancer cells to trigger a reaction within tumor cells through neutron irradiation. In this research, safety and basic efficacy were examined in Phase 1 (safety confirmation stage), and Phase 2 is verifying the potential for clinical application by expanding the target diseases. *Specific clinical research is research aimed at evaluating treatments at medical institutions, based on the Clinical Research Act established by the Ministry of Health, Labour and Welfare. ■ [Latest Report] Specific Clinical Research Phase 2: Study targeting FDG-PET positive superficial tumors (jRCTs031240204 / Started August 2024) Based on the results of the Phase 1 study, specific clinical research targeting FDG-PET positive superficial tumors was conducted starting in August 2024. A total of 10 patients were enrolled in this study, and all have completed BNCT treatment and necessary follow-up observations. Of these cases, 9 were female, with breast cancer accounting for 7 of them. Conventionally, FBPA-PET has been used in BNCT to evaluate the accumulation of boron compounds in tumors, but facilities capable of performing this test are limited. On the other hand, FDG-PET is widely used in clinical settings to evaluate the metabolic activity of cancer cells, so this study uses FDG-PET to evaluate and examine its utility. https://www.edogawa.or.jp/features/bnct/research-report.html ▼ Specific observation progress in cases The following changes have been observed in individual cases: ・4th case of BNCT for FDG-PET positive superficial tumors (jRCTs031240204): Recurrent breast cancer A tumor that was approximately 37mm before treatment disappeared in diagnostic imaging 3 months after treatment. Additionally, the tumor marker (CA15-3), which was originally within the standard range (25 or less), decreased from 20.9 to 10.7. ・10th case of BNCT for FDG-PET positive superficial tumors (jRCTs031240204): Primary breast cancer (untreated) Accumulation in FDG-PET decreased from SUV5 to SUV1. The tumor became undetectable by palpation one month after treatment, and no tumor was confirmed in diagnostic imaging 2 to 4 months later. (Effect evaluation is CR)