Streamlining staging of lung and colorectal cancer with whole body MRI; study protocols for two multicentre, non-randomised, single-arm, prospective diagnostic accuracy studies (Streamline C and Streamline L)

BMC Cancer

Study Protocol

Anne Miles¹  Alison Morton²  Alf Oliver²  Vicky Goh³  Sandy Beare⁴  Steve Halligan⁵  Shonit Punwani⁵  Stuart A. Taylor⁵  Gauraang Bhatnagar⁵  Steve Morris⁶  Dow Mu Koh⁷  Andrea G. Rockall⁸  Ashley M. Groves⁹  Sam M. Janes^1,10  Neal Navani^1,11  Rob Glynne-Jones^1,12  Anwar R. Padhani^1,13  Sue Mallett^1,14  John Bridgewater^1,15 

[1] Birkbeck, University of London, Malet Street, WC1E 7HX, London, UK;C/O National Cancer Research Institute, 407 St Johns Street, EC1V 4AD, London, UK;Cancer Imaging, Division of Imaging Sciences & Biomedical Engineering Kings College London, St Thomas Hospital, Westminster Bridge Road, SE1 7EH, London, UK;Cancer Research UK & UCL Cancer Trials Centre, 90 Tottenham Court Road, W1T 4TJ, London, UK;Centre for Medical Imaging, University College London, 250 Euston Road, NW1 2BU, London, UK;Department of Applied Health Research, University College London, 1-19 Torrington Pl, Fitzrovia, WC1E 7HB, London, UK;Department of Radiology, Royal Marsden Hospital, Downs Road, SM2 5PT, Sutton, UK;Department of Radiology, Royal Marsden NHS Foundation Trust, Fulham Rd London, SW3 6JJ, London, UK;Division of Cancer and Surgery, Faculty of Medicine, Hammersmith Campus, Imperial College London, W12 ONN, London, UK;Institute of Nuclear Medicine, University College London, Euston Rd, London, UK;Lungs for Living Research Centre, UCL Respiratory, University College London, 5 University Street, WC1E 6JF, London, UK;Lungs for Living Research Centre, UCL Respiratory, University College London, 5 University Street, WC1E 6JF, London, UK;Department of Thoracic Medicine, University College London Hospital, 250 Euston Road, NW1 2PG, London, UK;Mount Vernon Centre for Cancer Treatment, Rickmansworth Road, MIDDX, HA6 2RN, Northwood, UK;Paul Strickland Scanner Centre, Mount Vernon Hospital, Middlesex, UK;School of Health and Population Sciences, University of Birmingham, Edgbaston, B15 2TT, Birmingham, UK;UCL Cancer Institute, Paul O Gorman Building, 72 Huntley Street London, WC1E 6DD, London, UK;

关键词: Colorectal cancer;    Lung cancer;    Staging;    Computed tomography;    Whole body magnetic resonance imaging;    Positron emission tomography;    Patient experience;   

DOI  :  10.1186/s12885-017-3281-x

 received in 2016-12-29, accepted in 2017-04-13,  发布年份 2017

来源: Springer

【 摘 要 】

Background and aimsRapid and accurate cancer staging following diagnosis underpins patient management, in particular the identification of distant metastatic disease. Current staging guidelines recommend sequential deployment of various imaging platforms such as computerised tomography (CT) and positron emission tomography (PET) which can be time and resource intensive and onerous for patients. Recent studies demonstrate that whole body magnetic resonance Imaging (WB-MRI) may stage cancer efficiently in a single visit, with potentially greater accuracy than current staging investigations. The Streamline trials aim to evaluate whether WB-MRI increases per patient detection of metastases in non-small cell lung and colorectal cancer compared to standard staging pathways.MethodsThe Streamline trials are multicentre, non-randomised, single-arm, prospective diagnostic accuracy studies with a novel design to capture patient management decisions during staging pathways. The two trials recruit adult patients with proven or highly suspected new diagnosis of primary colorectal (Streamline C) or non-small cell lung cancer (Streamline L) referred for staging. Patients undergo WB-MRI in addition to standard staging investigations. Strict blinding protocols are enforced for those interpreting the imaging. A first major treatment decision is made by the multi-disciplinary team prior to WB-MRI revelation based on standard staging investigations only, then based on the WB-MRI and any additional tests precipitated by WB-MRI, and finally based on all available test results. The reference standard is derived by a multidisciplinary consensus panel who assess 12 months of follow-up data to adjudicate on the TNM stage at diagnosis. Health psychology assessment of patients’ experiences of the cancer staging pathway will be undertaken via interviews and questionnaires. A cost (effectiveness) analysis of WB-MRI compared to standard staging pathways will be performed.DiscussionWe describe a novel approach to radiologist and clinician blinding to ascertain the ‘true’ diagnostic accuracy of differing imaging pathways and discuss our approach to assessing the impact of WB-MRI on clinical decision making in real-time. The Streamline trials will compare WB-MRI and standard imaging pathways in the same patients, thereby informing the most accurate and efficient approach to staging.Trial registrationStreamline C ISRCTN43958015 (registered 25/7/2012). Streamline L ISRCTN50436483 (registered 31/7/2012).

【 授权许可】

CC BY   
© Crown copyright. 2017