title: A paradigm shift in tumour response evaluation of targeted therapy:  the assessment of novel drugs in exploratory clinical trials.
abstract: OBJECTIVE
  To describe the difficulty in assessing the biological activity of a novel agent in phase II trials.
  
  
  RESULTS
  Two major fields of research provide interesting new potential endpoints: endpoints based on new imaging techniques (e.g. PET or spectral imaging that explore tumour metabolism, dynamic contrast enhanced (DCE) ultrasonography or DCE-MRI that explore tumour vascularization and tumour growth inhibition) and endpoints integrating assessment of tumour burden across time, such as the growth modulation index.
  
  
  CONCLUSIONS
  Most of the recently described techniques appear attractive, but require formal validation.
authors.affiliation: General Oncology Department, Oscar Lambret Cancer Center, Research Unit EA 2694, Medical School, Lille-Nord-de-France University, Lille, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Cousin
authors.forename: Sophie
authors.initials: S
authors.lastname: Taieb
authors.forename: Nicolas
authors.initials: N
authors.lastname: Penel
mesh_terms: D017322:Clinical Trials, Phase II as Topic; D018572:Disease-Free Survival; D015195:Drug Design; D006801:Humans; D008279:Magnetic Resonance Imaging; D058990:Molecular Targeted Therapy / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D014057:Tomography, X-Ray Computed; D047368:Tumor Burden