Boronophenylalanine (BPA)-Based Boron Neutron Capture Therapy (BNCT) in the Treatment of Inoperable and Irradiated Head and Neck Tumors: A Feasibility Study
This is a single BNCT-facility, non-randomized, non-comparative, open-label, phase I to II
trial to determine the value of BNCT in the treatment of inoperable, irradiated, locally
advanced cancers of the head and neck region. An attempt to perform 18F-labeled
boronophenylalanine (18F-BPA) SPECT or PET imaging will be made before BNCT. Patients whose
tumor uptake is >2.5 times that of the corresponding normal head and neck tissue will be
enrolled, and treated with a single fraction BPA-based BNCT twice, 3 to 5 weeks apart.
Another 18F-BPA SPECT or PET study may be performed 1 to 3 months after BNCT to determine
the SPECT/PET response.
The neutron irradiation site is the FiR 1 reactor site, located at Otaniemi, Espoo, Finland,
about 6 kilometers from the Helsinki University Central Hospital, Helsinki, where patient
evaluation and post-irradiation care will take place.
Prior to BNCT, BPA is infused as a fructose complex (l-BPA-F) into a peripheral vein over 2
hours. Blood samples will be taken for monitoring whole blood boron concentration before
starting the BPA infusion, and thereafter at 20 to 40 minute intervals during the infusion,
following infusion, and after delivering neutron irradiation. The blood samples will be
analyzed for blood boron concentration to estimate the average blood boron concentration
during neutron irradiation.
All patients will be evaluated for response using CT or magnetic resonance imaging (MRI).
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Heikki T Joensuu, M.D., prof.
Helsinki University Central Hospital
Finland: Finnish Medicines Agency