Prospective, longitudinal, multi-modal functional imaging for radical chemo-IMRT treatment of locally advanced XXXX : the INSIGHT study.

@entity1 @entity135 @entity5
BACKGROUND: Radical chemo-radiotherapy (CRT) is an effective organ-sparing treatment option for @entity1 with locally advanced @entity135 (LAHNC). Despite advances in treatment for LAHNC, a significant minority of these @entity1 continue to fail to achieve complete response with standard CRT. By constructing a multi-modality functional imaging (FI) predictive biomarker for CRT outcome for @entity1 with LAHNC we hope to be able to reliably identify those @entity1 at high risk of failing standard CRT. Such a biomarker would in future enable CRT to be tailored to the specific biological characteristics of each @entity1 ' @entity5 , potentially leading to improved treatment outcomes. METHODS/DESIGN: The INSIGHT study is a single-centre, prospective, longitudinal multi-modality imaging study using functional MRI and FDG-PET/CT for @entity1 with @entity5 receiving radical CRT. Two cohorts of @entity1 are being recruited: one treated with, and another treated without, induction chemotherapy. All @entity1 receive radical intensity modulated radiotherapy with concurrent chemotherapy. @entity1 undergo functional imaging before, during and 3  months after completion of radiotherapy, as well as at the time of relapse, should that occur within the first two years after treatment. Serum samples are collected from @entity1 at the same time points as the FI scans for analysis of a panel of serum markers of @entity5 . DISCUSSION: The primary aim of the INSIGHT study is to acquire a prospective multi-parametric longitudinal data set comprising functional MRI, FDG PET/CT, and serum biomarker data from @entity1 with LAHNC undergoing primary radical CRT. This data set will be used to construct a predictive imaging biomarker for outcome after CRT for LAHNC. This predictive imaging biomarker will be used in future studies of functional imaging based treatment stratification for @entity1 with LAHNC. Additional objectives are: defining the reproducibility of FI parameters; determining robust methods for defining FI based biological target volumes for IMRT planning; creation of a searchable database of functional imaging data for data mining. The INSIGHT study will help to establish the role of FI in the clinical management of LAHNC. TRIAL REGISTRATION: NCRI H_N CSG ID 13860.
