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International Journal of
eISSN: 2574-8084

Radiology & Radiation Therapy

Review Article Volume 13 Issue 2

Recent regulatory consents and clinical translation of neutron radiotherapy: A PRISMA-aligned systematic review of Boron Neutron Capture Therapy (BNCT)

Nina Tunçel

Department of Radiation Oncology Physics, Akdeniz University, Turkey

Correspondence: Nina Tunçel, Department of Radiation Oncology Physics, Akdeniz University, Turkey

Received: February 21, 2026 | Published: March 4, 2026

Citation: Tunçel N. Recent regulatory consents and clinical translation of neutron radiotherapy: A PRISMA-aligned systematic review of Boron Neutron Capture Therapy (BNCT). Int J Radiol Radiat Ther. 2026;4(1):39-40. DOI: 10.15406/ijrrt.2026.13.00451

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Abstract

Objective: This systematic review evaluates the clinical efficacy, safety profile, dosimetric methodology, and regulatory translation of Boron Neutron Capture Therapy (BNCT).

Methods: A PRISMA-aligned search of PubMed, Scopus, Web of Science, and Embase was conducted for studies published between 2000 and 2025. Clinical trials, retrospective analyses, regulatory documents, and accelerator-based implementation reports were included.

Results: Forty-two studies met inclusion criteria. Accelerator-based BNCT demonstrated local control rates between 60–85% in recurrent head and neck cancers. Glioblastoma cohorts reported median overall survival between 10–18 months. Japan remains the first country granting national regulatory approval.

Conclusion: BNCT represents a translational radiotherapy platform with growing clinical validation. However, randomized controlled trials remain limited.

Keywords: boron neutron capture therapy, accelerator-based neutron sources, clinical outcomes in head and neck cancer, glioblastoma survival extension, dosimetry and monte carlo simulations, compound biological effectiveness, relative biological effectiveness, PRISMA systematic review methodology

Introduction

BNCT is a binary radiotherapeutic modality relying on selective boron-10 accumulation followed by neutron irradiation, producing high-LET alpha particles and lithium nuclei.1–5 The short particle range allows cellular-level dose confinement. Transition from reactor-based neutron beams to accelerator-based systems has facilitated hospital deployment.6–9

Methods (PRISMA Framework)

A systematic search strategy was conducted using predefined keywords related to BNCT, accelerator neutron sources, regulatory approval, and clinical outcomes.10–12 Inclusion criteria encompassed human clinical studies, regulatory publications, and prospective cohort trials. Risk of bias was qualitatively assessed following Cochrane principles.13

Radiobiological basis

BNCT effectiveness depends on compound biological effectiveness (CBE) and relative biological effectiveness (RBE) modeling.14–18 Mixed radiation fields include thermal neutrons, fast neutrons, gamma contamination, and boron dose components. Monte Carlo simulations are essential for dose modeling.19–21

Clinical outcomes

Recurrent head and neck cancers show favorable response rates with acceptable toxicity profiles.22–25 Glioblastoma remains challenging but demonstrates survival extension in selected cohorts.26–28 Melanoma and cutaneous metastases have also been treated.29–30

Regulatory landscape

Japan’s Pharmaceuticals and Medical Devices Agency approval of accelerator-based BNCT marked a milestone in 2020.31–32 Finland and Argentina have implemented hospital-based systems under national regulatory oversight.33–34

Discussion

Heterogeneity in boron pharmacokinetics, neutron spectra, and dosimetry protocols limits cross-study comparability.35–37 Multicenter randomized trials and standardized reporting frameworks are required for global adoption.38–39

Conclusion

BNCT demonstrates strong translational potential supported by technological advances and regulatory recognition. Future integration depends on harmonized dosimetry and high-level evidence generation.40

Conflicts of interest

Author declare that there is no conflicts of interest.

Acknowledgement

None.

References

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©2026 Tunçel. This is an open access article distributed under the terms of the, which permits unrestricted use, distribution, and build upon your work non-commercially.

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