Abstract Boron neutron capture therapy (BNCT) has been attracting interest as a new radiation modality for cancer therapy because it can selectively destroy cancer cells while maintaining the healthy state of surrounding normal cells. Many experimental trials have demonstrated significant BNCT treatment efficacy using neutron beams from research reactors. However, nuclear reactor technology cannot be scaled to sites in hospitals delivering patient treatment. Therefore, compact accelerator-based neutron sources that could be installed in many hospitals are under development or have even been commissioned at many facilities around the world. In Korea, a radio-frequency (RF) linac-based BNCT (A-BNCT) facility is under development by DawonMedax (DM). It provides the highly efficient production of an epithermal neutron beam with an optimized neutron energy spectrum range of 0.1~10 keV. With a 2-mA 10-MeV proton beam from the accelerator, the irradiation port epithermal neutron flux is higher than 1 × 10 9 n/cm 2 ⋅s. Comprehensive verification and validation of the system have been conducted with the measurement of both proton and neutron beam characteristics. Significant therapeutic effects from BNCT have been confirmed by DM in both in vitro and in vivo non-clinical trials. Further, during exposure to epithermal neutrons, all other unintended radiation is controlled to levels meeting International Atomic Energy Agency (IAEA) recommendations. Recently, the Korean FDA has accepted an investigational new drug (IND) and the first-in-human clinical trial of BNCT is now being prepared. This paper introduces the principles of BNCT and accelerator-based neutron sources for BNCT and reports the recent advances of DM A-BNCT facility which is the main part of this paper. 

https://link.springer.com/content/pdf/10.1007/s43673-022-00063-2.pdf

Advances of LINAC-based boron neutron capture therapy in Korea

Abstract Boron neutron capture therapy (BNCT) is a cancer treatment modality based on the nuclear capture and fission reactions that occur when boron‐10, a stable isotope, is irradiated with neutrons of the appropriate energy to produce boron‐11 in an unstable form, which undergoes instantaneous nuclear fission to produce high‐energy, tumoricidal alpha particles. The primary purpose of this review is to provide an update on the first drug used clinically, sodium borocaptate (BSH), by the Japanese neurosurgeon Hiroshi Hatanaka to treat patients with brain tumors and the second drug, boronophenylalanine (BPA), which first was used clinically by the Japanese dermatologist Yutaka Mishima to treat patients with cutaneous melanomas. Subsequently, BPA has become the primary drug used as a boron delivery agent to treat patients with several types of cancers, specifically brain tumors and recurrent tumors of the head and neck region. The focus of this review will be on the initial studies that were carried out to define the pharmacokinetics and pharmacodynamics of BSH and BPA and their biodistribution in tumor and normal tissues following administration to patients with high‐grade gliomas and their subsequent clinical use to treat patients with high‐grade gliomas. First , we will summarize the studies that were carried out in Japan with BSH and subsequently at our own institution, The Ohio State University, and those of several other groups. Second , we will describe studies carried out in Japan with BPA and then in the United States that have led to its use as the primary drug that is being used clinically for BNCT. Third , although there have been intense efforts to develop new and better boron delivery agents for BNCT, none of these have yet been evaluated clinically. The present report will provide a guide to the future clinical evaluation of new boron delivery agents prior to their clinical use for BNCT. 

Evaluation of sodium borocaptate (BSH) and boronophenylalanine (BPA) as boron delivery agents for neutron capture therapy (NCT) of cancer: an update and a guide for the future clinical evaluation of new boron delivery agents for NCT

Abstract Accelerator-based boron neutron capture therapy (BNCT) systems employing a solid-state lithium target indicated the reduction of neutron flux over the lifetime of a target, and its reduction could represent the neutron flux model. This study proposes a novel compensatory approach for delivering the required neutron fluence and validates its clinical applicability. The proposed approach relies on the neutron flux model and the cumulative sum of real-time measurements of proton charges. The accuracy of delivering the required neutron fluence for BNCT using the proposed approach was examined in five Li targets. With the proposed approach, the required neutron fluence could be delivered within 3.0%, and within 1.0% in most cases. However, those without using the proposed approach exceeded 3.0% in some cases. The proposed approach can consider the neutron flux reduction adequately and decrease the effect of uncertainty in neutron measurements. Therefore, the proposed approach can improve the accuracy of delivering the required fluence for BNCT even if a neutron flux reduction is expected during treatment and over the lifetime of the Li target. Additionally, by adequately revising the approach, it may apply to other type of BNCT systems employing a Li target, furthering research in this direction. 

A method for delivering the required neutron fluence in an accelerator-based boron neutron capture therapy system employing a lithium target

In boron neutron capture therapy (BNCT), patient dose is contingent upon boron concentration and neutron irradiation. This study details the creation and implementation of a real-time beam-monitoring system using a Eu:LiCaAlF6 (LiCAF) scintillation detector. This system precisely regulates neutron irradiation according to the treatment plan. A two-step calibration process was employed for enhanced reliability. The initial calibration used an Americium–Beryllium (AmBe) source to isolate neutron signals from a mix of gamma and neutron signals. The second calibration involved a polymethyl methacrylate (PMMA) moderator within the BNCT beam, calibrated against the gold-foil activation method. This yielded a thermal neutron reaction rate with an uncertainty of approximately 2.62 % (k = 2). For continuous monitoring, the system includes a detector with a polyethylene (PE) moderator and an internal LiCAF placed inside the beam port. This monitoring system calculates and displays the epithermal neutron flux by comparing the flux at the beam port to the thermal neutron flux from the moderator. The performance of the installed system was evaluated, noting an uncertainty in epithermal neutron conversion of 3.3 % (k = 2) and a linearity exceeding 0.99 (R2 > 0.99). Operational from December 2022 to April 2023 in clinical trials, the system was subjected to regular quality assurance checks on an annual, monthly, and daily basis, showing no performance degradation or unusual operation. Future work will focus on collecting data to determine the lifespan of the LiCAF detector through continued monitoring. 

Real-time neutron beam monitor utilizing scintillator technology for boron neutron capture therapy

Boron neutron capture therapy: a promising radiation treatment modality.

Boron neutron capture therapy (BNCT) is a radiation therapy that selectively kills cancer cells and is being actively researched and developed around the world. In Korea, development of the proton linear accelerator-based BNCT system has completed development, and its anti-cancer effect in the U-87 MG subcutaneous xenograft model has been evaluated. To evaluate the efficacy of BNCT, we measured 10B-enriched boronophenylalanine (BPA) uptake in U-87 MG, FaDu, and SAS cells and evaluated cell viability by clonogenic assays. In addition, the boron concentration in the tumor, blood, and skin on the U-87 MG xenograft model was measured, and the tumor volume was measured for 4 weeks after BNCT. In vitro, the intracellular boron concentration was highest in the order of SAS, FaDu, and U-87 MG, and cell survival fractions decreased depending on the BPA treatment concentration and neutron irradiation dose. In vivo, the tumor volume was significantly decreased in the BNCT group compared to the control group. This study confirmed the anti-cancer effect of BNCT in the U-87 MG subcutaneous xenograft model. It is expected that the proton linear accelerator-based BNCT system developed in Korea will be a new option for radiation therapy for cancer treatment.

/pdf/the-anti-tumor-effect-of-boron-neutron-capture-therapy-in-1lgnc92d.pdf

The Anti-Tumor Effect of Boron Neutron Capture Therapy in Glioblastoma Subcutaneous Xenograft Model Using the Proton Linear Accelerator-Based BNCT System in Korea

The therapeutic effects on U87 and SAS cells using Proton Linac based Boron Neutron Capture Therapy in Korea.

Commissioning of proton linac-based bnct system and the current status of its clinical trials in korea

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Advances of LINAC-based boron neutron capture therapy in Korea

The Anti-Tumor Effect of Boron Neutron Capture Therapy in Glioblastoma Subcutaneous Xenograft Model Using the Proton Linear Accelerator-Based BNCT System in Korea

The therapeutic effects on U87 and SAS cells using Proton Linac based Boron Neutron Capture Therapy in Korea.

Commissioning of proton linac-based bnct system and the current status of its clinical trials in korea