Clinical Trials in BNCT: A Challenging Task

Chapter

Abstract

Clinical trials are essential for medical progress as new treatments must be proven to be safe and efficient before eventually accepted as standard. The treatment concept of Boron Neutron Capture Therapy (BNCT) varies fundamentally from conventional therapies. The main distinctions are the binary nature of the treatment principle, which requires investigation of a compound susceptible of targeting tumor cells however without an own therapeutic effect. Radiation facilities and beams used for BNCT to date differ considerably not only from facilities and beams used for conventional radiotherapy, but beams used for BNCT also differ among themselves and often must first be licensed for patient treatments. Therefore, the development of BNCT to treatment modality needs strategies, which are based on the classical trial concept but meet the challenges and characteristics of BNCT. Understood, all applicable laws and regulations for conducting clinical trials must be respected. These aspects make clinical trials in BNCT a challenging task for the clinical scientists as well as for the regulatory authorities.

Keywords

Boron Neutron Capture Therapy Binary Nature Subtherapeutic Dose Clinical Trial Protocol Trial Concept 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  1. 1.Department of Radiotherapy and Radiation OncologyPhilipps-University MarburgMarburgGermany
  2. 2.NCTeam, Department of Radiation OncologyUniversity Hospital Essen, University Duisburg-EssenEssenGermany

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