A paradigm shift in tumour response evaluation of targeted therapy: the assessment of novel drugs in exploratory clinical trialsCousin, Sophiea; Taieb, Sophieb; Penel, Nicolasa,cCurrent Opinion in Oncology: May 2012 - Volume 24 - Issue 3 - p 338–344 doi: 10.1097/CCO.0b013e3283528b73 INNOVATIVE EARLY CLINICAL TRIALS METHODOLOGY AND NEW THERAPEUTICS IN CANCER: Edited by Ahmad Awada Buy Abstract Author InformationAuthors Article MetricsMetrics Purpose of review To describe the difficulty in assessing the biological activity of a novel agent in phase II trials. Recent findings 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. Summary Most of the recently described techniques appear attractive, but require formal validation. aGeneral Oncology Department bDepartment of Medical Imaging, Oscar Lambret Cancer Center cResearch Unit EA 2694, Medical School, Lille-Nord-de-France University, Lille, France Correspondence to Nicolas Penel, MD, PhD, General Oncology Department, Centre Oscar Lambret, 3 rue Frédéric Combemale, 59020 Lille, France. Tel: +33 3 2029 5920; fax: +33 3 2029 5963; e-mail: firstname.lastname@example.org © 2012 Lippincott Williams & Wilkins, Inc.