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: Research 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. In this study, a total of 10 patients were enrolled, 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 the number of facilities capable of performing this test is limited. On the other hand, FDG-PET is widely used in clinical practice 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 clinical observations in cases

The following changes have been observed in individual cases:

・BNCT for FDG-PET positive superficial tumors (jRCTs031240204) Case 4: Recurrent breast cancer

A tumor measuring 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.

・BNCT for FDG-PET positive superficial tumors (jRCTs031240204) Case 10: Primary breast cancer (untreated)

Accumulation in FDG-PET decreased from SUV5 to SUV1. At 1 month after treatment, the tumor could no longer be confirmed by palpation, and the tumor was not confirmed in subsequent diagnostic imaging at 2 to 4 months. (Effectiveness judgment is CR)