title: Prospective, longitudinal, multi-modal functional imaging for radical chemo-IMRT treatment of locally advanced head and neck cancer: the INSIGHT study.
abstract: BACKGROUND
  Radical chemo-radiotherapy (CRT) is an effective organ-sparing treatment option for patients with locally advanced head and neck cancer (LAHNC). Despite advances in treatment for LAHNC, a significant minority of these patients continue to fail to achieve complete response with standard CRT. By constructing a multi-modality functional imaging (FI) predictive biomarker for CRT outcome for patients with LAHNC we hope to be able to reliably identify those patients 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 patients' tumour, potentially leading to improved treatment outcomes.
  
  
  METHODS
  The INSIGHT study is a single-centre, prospective, longitudinal multi-modality imaging study using functional MRI and FDG-PET/CT for patients with LAHNC squamous cell carcinomas receiving radical CRT. Two cohorts of patients are being recruited: one treated with, and another treated without, induction chemotherapy. All patients receive radical intensity modulated radiotherapy with concurrent chemotherapy. Patients 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 patients at the same time points as the FI scans for analysis of a panel of serum markers of tumour hypoxia.
  
  
  CONCLUSIONS
  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 patients 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 patients 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.
  
  
  BACKGROUND
  NCRI H&N CSG ID 13860.
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Liam.Welsh@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Liam.Welsh@icr.ac.uk.|Clinical Research Fellow, Head and Neck Unit, Royal Marsden Hospital, Sutton, Surrey, SM2 5PT, UK. Liam.Welsh@icr.ac.uk.
authors.forename: Liam
authors.initials: L
authors.lastname: Welsh
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Rafal.Panek@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Rafal.Panek@icr.ac.uk.
authors.forename: Rafal
authors.initials: R
authors.lastname: Panek
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Dualta.McQuaid@rmh.nhs.uk.
authors.forename: Dualta
authors.initials: D
authors.lastname: McQuaid
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Alex.Dunlop@rmh.nhs.uk.
authors.forename: Alex
authors.initials: A
authors.lastname: Dunlop
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Maria.Schmidt@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Maria.Schmidt@icr.ac.uk.
authors.forename: Maria
authors.initials: M
authors.lastname: Schmidt
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Angela.Riddell@rmh.nhs.uk.
authors.forename: Angela
authors.initials: A
authors.lastname: Riddell
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Dow-Mu.Koh@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Dow-Mu.Koh@icr.ac.uk.
authors.forename: Dow-Mu
authors.initials: DM
authors.lastname: Koh
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Simon.Doran@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Simon.Doran@icr.ac.uk.
authors.forename: Simon
authors.initials: S
authors.lastname: Doran
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Iain.Murray@rmh.nhs.uk.
authors.forename: Iain
authors.initials: I
authors.lastname: Murray
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Yong.Du@rmh.nhs.uk.
authors.forename: Yong
authors.initials: Y
authors.lastname: Du
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Sue.Chua@rmh.nhs.uk.
authors.forename: Sue
authors.initials: S
authors.lastname: Chua
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Vibeke.Hansen@rmh.nhs.uk.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Hansen
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Kee.Wong@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Kee.Wong@icr.ac.uk.
authors.forename: Kee H
authors.initials: KH
authors.lastname: Wong
authors.affiliation: The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Jamie.Dean@icr.ac.uk.
authors.forename: Jamie
authors.initials: J
authors.lastname: Dean
authors.affiliation: The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Sarah.Gulliford@icr.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Gulliford
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Shree.Bhide@rmh.nhs.uk.
authors.forename: Shreerang
authors.initials: S
authors.lastname: Bhide
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Martin.Leach@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Martin.Leach@icr.ac.uk.
authors.forename: Martin O
authors.initials: MO
authors.lastname: Leach
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Chris.Nutting@rmh.nhs.uk.
authors.forename: Christopher
authors.initials: C
authors.lastname: Nutting
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Kevin.Harrington@icr.ac.uk.|The Institute of Cancer Research, 15 Cotswold Road, Sutton, Surrey, SM2 5NG, UK. Kevin.Harrington@icr.ac.uk.
authors.forename: Kevin
authors.initials: K
authors.lastname: Harrington
authors.affiliation: The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, UK. Kate.Newbold@rmh.nhs.uk.
authors.forename: Kate
authors.initials: K
authors.lastname: Newbold
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000378:metabolism / Q000473:pathology / Q000628:therapy; D059248:Chemoradiotherapy / Q000401:mortality*; D005260:Female; D006258:Head and Neck Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging / Q000379:methods*; D009364:Neoplasm Recurrence, Local / Q000378:metabolism / Q000473:pathology* / Q000628:therapy*; D009367:Neoplasm Staging; D049268:Positron-Emission Tomography / Q000379:methods; D011379:Prognosis; D011446:Prospective Studies; D011880:Radiotherapy Planning, Computer-Assisted / Q000379:methods*; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods; D014057:Tomography, X-Ray Computed / Q000379:methods; D055815:Young Adult