Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment

To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.
To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.

开始日期2025-04-10

申办/合作机构

Stella Pharma Corp.

[+1]

NCT05601232

/ Active, not recruiting临床2期

A Phase II Study of Boron Neutron Capture Therapy (BNCT) for Patients With Unresectable Angiosarcoma, by Using CICS-1 and SPM-011

The purpose of the study is to investigate efficacy and safety Boron Neutron Capture Therapy (BNCT) by using CICS-1 accelerator-based neutron capture therapy device with lithium targets developed by CICS, and the SPM-011 boron compound for use in BNCT developed by STELLA PHARMA in the treatment of unresectable angiosarcoma.

开始日期2022-11-01

申办/合作机构

Stella Pharma Corp.

[+1]

JPRN-JapicCTI-195062

/ Completed临床1期

Phase 1 clinical trial of Boron Neutron Capture Therapy (BNCT) using CICS-1 and SPM-011 for Malignant melanoma and angiosarcoma

开始日期2019-11-19

申办/合作机构

Cancer Intelligence Care Systems, Inc.

[+1]

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2025-08-01·Applied Radiation and Isotopes

Relative biological effectiveness of an accelerator-based BNCT system coupled to a solid-state lithium target: two different approaches for neutron beams

Article

作者: Chiba, Takahito ; Ishiai, Masamichi ; Nakamura, Satoshi ; Nakaichi, Tetsu ; Okamoto, Hiroyuki ; Goka, Tomonori ; Nakayama, Hiroki ; Shuto, Yasunori ; Kasai, Yusaku ; Murata, Homare ; Imamichi, Shoji ; Kobayashi, Yuta ; Takemori, Mihiro ; Igaki, Hiroshi ; Shimada, Kenzi ; Masutani, Mitsuko ; Endo, Hana ; Yonemura, Miki

The relative biological effectiveness (RBE) of neutrons in neutron beams is crucial for the clinical implementation of accelerator-based boron neutron capture therapy (BNCT) systems. The RBE was quantified by comparing the doses required to achieve a 10 % cell survival fraction (D10) between reference radiation (photons) and neutrons. However, in accelerator-based BNCT, the neutron beam includes not only neutrons but also contaminating gamma rays, making it essential to calculate the RBE of neutrons while accounting for the gamma-ray dose. The RBE of neutrons was calculated using a recently proposed method, which assumes that the interaction between neutrons and contaminating gamma rays is independent, and this was compared with the conventional method, which assumes that the interactions are not independent. These calculations were conducted in an accelerator-based BNCT system with a solid-state lithium target. A comparison was also performed by varying the representative beam parameters to validate the RBE values. Additionally, the photon isoeffective dose was implemented and compared with the RBE-weighted dose calculated from the two RBE values. Four cell lines (SAS, SCCVII, U87-MG, and NB1RGB) were used to assess the cell survival fraction (SF). The SF curves for neutrons and photons were derived using linear and linear-quadratic models, respectively, to calculate D10. For the four cell lines, the mean RBE value calculated using the conventional method was 1.9 (RBE1), while that calculated using the recent method was 2.0 (RBE2). Furthermore, when the photon isoeffective dose was calculated, it closely matched the RBE-weighted doses obtained using RBE1 and RBE2 from the four cell lines. This study also examined the impact of varying the ratio of contaminating gamma rays to neutron doses, a representative beam parameter, on RBE1 and RBE2. The RBE2 value remained independent of the ratio, whereas the RBE1 value increased with rising gamma-ray contamination. However, the two RBE values was comparable when the system was adequately designed for clinical BNCT use. Therefore, this study suggests that comparing the RBE values derived from the two different methods can confirm not only the validity of the RBE but also the representative beam parameters in accelerator-based BNCT.

2025-07-01·Applied Radiation and Isotopes

Feasibility study of accelerator-based boron neutron capture therapy for thoracic tumors: treatment planning aspect

Article

作者: Okamoto, Hiroyuki ; Murata, Homare ; Nakamura, Satoshi ; Kashihara, Tairo ; Nakayama, Hiroki ; Nishina, Shuka ; Kobayashi, Yuta ; Endo, Hana ; Hayashi, Toshimitsu ; Shuto, Yasunori ; Takemori, Mihiro ; Chiba, Takahito ; Igaki, Hiroshi ; Nishitani, Masato ; Nakaichi, Tetsu ; Yonemura, Miki ; Nakamura, Masaru

This study discusses the feasibility of accelerator-based boron neutron capture therapy (AB-BNCT) for thoracic cancers. Fourteen patients were enrolled: six with breast cancer, five with lung cancer, and three with esophageal cancer. Although BNCT is performed with a single fraction from a single beam direction, two-fraction treatments with different beam angles were considered to improve the dose of gross tumor volume (GTV) in cases where the dose constraint of GTV was not achieved. Relative biological effectiveness (RBE)-weighted dose distributions were calculated based on computed tomography (CT) images via Monte Carlo simulation (PHITS) to evaluate the dose to GTV and organs-at-risk (OARs). One-field irradiation plans in six patients (breast: 1, lung: 4, esophageal: 1) did not achieve the dose constraint of GTV owing to deep-seated or large tumors, whereas those in the other patients did. Among these six patients, the two-field irradiation plan improved the achievement rate of the dose constraint of GTV from zero to five patients and that of heart from five to six patients. Moreover, the 2-field irradiation plan improved the homogeneity index of GTV. Changing the appropriate dose prescription and number of treatment fractions according to the patient's condition can enhance the safe delivery of BNCT for thoracic cancers while delivering a sufficient dose to the tumors.

2025-01-01·Medical Physics

Development of an online neutron beam monitoring system for accelerator‐based boron neutron capture therapy in a hospital

Article

作者: Shimada, Kenzi ; Nakamura, Masaru ; Yagi, Natsumi ; Takada, Masashi ; Endo, Satoru ; Tanaka, Kenichi ; Nunomiya, Tomoya ; Itami, Jyun ; Narita, Masakuni ; Nakamura, Satoshi ; Aoyama, Kei ; Nakamura, Takashi ; Kajimoto, Tsuyoshi ; Igaki, Hiroshi

AbstractBackgroundBoron neutron capture therapy (BNCT) is a next‐generation radiotherapy, utilizing both an external neutron beam and a ‐containing pharmaceutical. A compact accelerator for a high intensity neutron source was installed to conduct BNCT in a hospital. The dose administered to a patient was evaluated by measuring the proton beam current.PurposeNeutron intensity should be monitored in real‐time by measuring the neutrons emitted from the target during BNCT irradiation. This is crucial due to potential neutron target degradation. Online neutron beam monitoring systems are required for reliable measurements of the administered neutron dose. An online neutron beam monitoring system was developed to monitor neutron intensity irradiating on the patient at the National Cancer Center Hospital (NCCH).MethodsThe neutron detector comprised a back‐illuminated thin Si diode of 40‐ thickness and an ultrathin natural LiF neutron converter of 0.05‐ thickness. The neutron detector was installed on the neutron target unit, regardless of whether a patient was present, without any additional modifications to the setup. The response functions for high photon dose rates of upto 100 Gy/h were measured. The pulse heights were measured using the neutron beam monitor during BNCT neutron irradiation. Neutron temporal response measured using the online beam monitor was acquired and compared with the proton beam current and the measurements at a patient position. From this measurement at the patient position, the neutron fluence rate irradiating on a patient was obtained.ResultsThe neutron events were separated from the photon events. The neutron counting rates increased rapidly with the starting of proton beam irradiation and dropped to zero upon its termination. During intermittent drops and recoveries in the proton beam, the neutron beam monitor for counting rates responded quickly, synchronizing with the beam current. A scatter plot of the neutron counting rate and proton beam current indicated a good linear correlation. A direct relationship between the online neutron beam monitor's neutron counting rates and those of the patient neutron detector showed a good correlation coefficient of 0.84. A ratio of the both neutron counting rates showed a standard deviation of 6%. The correlation coefficient and standard deviation were improved to 0.94 and 1.5%, by re‐binning the neutron temporal response with longer acquisition period than 1 s. Using the online neutron beam monitor, the neutron fluence rate was obtained from the direct relationship within 1.5%. Therefore, real‐time monitoring of neutron intensity was achieved within the acceptable level as per the International Commission on Radiation Units and Measurements report.ConclusionsThe online neutron beam monitoring system was developed to monitor the BNCT neutron beam intensity at NCCH. The temporal response of the neutron beam monitor was synchronized with the neutron counting rate at the patient position. Using the online neutron beam monitor, the neutron fluence rate irradiating on the patient can be monitored from the direct relationship. Fluctuation of the neutron beam intensity through BNCT irradiation and the degradation of the lithium target through the lifespan of the neutron target could be monitored using the neutron beam monitor.

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