Strategic Clinical Trial Design for Boron Neutron Capture Therapy

Boron neutron capture therapy (BNCT) involves infusion of cancer patients with a tumor-seeking, boron-loaded compound and irradiation by a beam of neutrons, with an energy range of 1 eV-10 keV. Neutron capture in the B-10 atoms results in an effective lethal radiation dose to the tumor cells, while sparing the healthy tissue. Recently available accelerator-based irradiation facilities facilitate developing BNCT to a treatment modality. However, the binary principle of BNCT, together with other points, is challenging in designing clinical trials that allow a timely and safe introduction of this innovative targeted modality into clinical practice. We propose a methodological framework to work toward a systematic, coordinated, and internationally accepted and evidence-based approach.

Automated summary

Boron neutron capture therapy (BNCT) involves infusing cancer patients with boron-loaded compounds and irradiating them with neutrons. This treatment effectively kills tumor cells while sparing healthy tissue. The challenge lies in designing clinical trials for timely and safe implementation of BNCT. To address this, a methodological framework is proposed for a systematic, coordinated, internationally accepted, and evidence-based approach.