Accelerator-Based BNCT and Opening of Phase I Clinical Trial at Helsinki University Hospital
We are pleased to announce that boron neutron capture therapy (BNCT) treatments have commenced at the Comprehensive Cancer Centre of Helsinki University Hospital (HUS CCC), Finland. Building on our previous experience with reactor-based BNCT from 1999 to 2012, this represents the first clinical implementation of accelerator-based BNCT in the Western hemisphere, using the nuBeam device manufactured and operated by Neutron Therapeutics, Inc. The treatment suite is located within the hospital area, providing easy access to all necessary hospital infrastructure and supporting patient management and clinical logistics.
Our first clinical investigation—a Phase I, open-label, dose-escalation study—is now open and actively recruiting. The trial aims to evaluate the safety, tolerability, and feasibility of accelerator-based BNCT in patients with locally recurrent head and neck carcinoma who have no remaining standard treatment options.
The primary objective of the study is to demonstrate the safety of accelerator-based neutron radiation. Secondary objectives include confirming the ability to deliver the planned radiation dose to the target site, dose calculation using the treatment planning software, accurately positioning and targeting the tumor site using the robotic patient table integrated with the CT scanner, and calculating the required radiation dose for each treatment within this trial.
To establish these objectives, the study will assess key clinical and technical parameters, including objective response rate, duration of response, clinical benefit rate (complete or partial response, or stable disease for at least 8 weeks), locoregional recurrence-free survival, progression-free survival, overall survival, and quality of life. More information can be found at ClinicalTrials.gov (identifier: NCT07058116).
Following the safety trial, new BNCT studies with broader indications are being prepared. The BNCT team at HUS CCC (pictured) looks forward to collaborating on upcoming trials, exploring BNCT both as a standalone therapy and in combination with other treatments.
VENLA LOIMU AND MIKKO TENHUNEN
on behalf of the whole HELSINKI BNCT TEAM
