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)

Abstract Background and aims Rapid 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...

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Main Authors: Stuart A. Taylor, Sue Mallett, Anne Miles, Sandy Beare, Gauraang Bhatnagar, John Bridgewater, Rob Glynne-Jones, Vicky Goh, Ashley M. Groves, Sam M. Janes, Dow Mu Koh, Steve Morris, Alison Morton, Neal Navani, Alf Oliver, Anwar R. Padhani, Shonit Punwani, Andrea G. Rockall, Steve Halligan
Format: Article
Language:English
Published: BMC 2017-05-01
Series:BMC Cancer
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12885-017-3281-x
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author Stuart A. Taylor
Sue Mallett
Anne Miles
Sandy Beare
Gauraang Bhatnagar
John Bridgewater
Rob Glynne-Jones
Vicky Goh
Ashley M. Groves
Sam M. Janes
Dow Mu Koh
Steve Morris
Alison Morton
Neal Navani
Alf Oliver
Anwar R. Padhani
Shonit Punwani
Andrea G. Rockall
Steve Halligan
author_facet Stuart A. Taylor
Sue Mallett
Anne Miles
Sandy Beare
Gauraang Bhatnagar
John Bridgewater
Rob Glynne-Jones
Vicky Goh
Ashley M. Groves
Sam M. Janes
Dow Mu Koh
Steve Morris
Alison Morton
Neal Navani
Alf Oliver
Anwar R. Padhani
Shonit Punwani
Andrea G. Rockall
Steve Halligan
author_sort Stuart A. Taylor
collection DOAJ
description Abstract Background and aims Rapid 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. Methods The 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. Discussion We 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 registration Streamline C ISRCTN43958015 (registered 25/7/2012). Streamline L ISRCTN50436483 (registered 31/7/2012).
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spelling doaj.art-04f11c7420ac42cbbb9592f2e4b89c1b2022-12-22T03:10:35ZengBMCBMC Cancer1471-24072017-05-0117111010.1186/s12885-017-3281-xStreamlining 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)Stuart A. Taylor0Sue Mallett1Anne Miles2Sandy Beare3Gauraang Bhatnagar4John Bridgewater5Rob Glynne-Jones6Vicky Goh7Ashley M. Groves8Sam M. Janes9Dow Mu Koh10Steve Morris11Alison Morton12Neal Navani13Alf Oliver14Anwar R. Padhani15Shonit Punwani16Andrea G. Rockall17Steve Halligan18Centre for Medical Imaging, University College LondonSchool of Health and Population Sciences, University of BirminghamBirkbeck, University of LondonCancer Research UK & UCL Cancer Trials CentreCentre for Medical Imaging, University College LondonUCL Cancer InstituteMount Vernon Centre for Cancer TreatmentCancer Imaging, Division of Imaging Sciences & Biomedical Engineering Kings College London, St Thomas HospitalInstitute of Nuclear Medicine, University College LondonLungs for Living Research Centre, UCL Respiratory, University College LondonDepartment of Radiology, Royal Marsden HospitalDepartment of Applied Health Research, University College LondonC/O National Cancer Research InstituteLungs for Living Research Centre, UCL Respiratory, University College LondonC/O National Cancer Research InstitutePaul Strickland Scanner Centre, Mount Vernon HospitalCentre for Medical Imaging, University College LondonDepartment of Radiology, Royal Marsden NHS Foundation TrustCentre for Medical Imaging, University College LondonAbstract Background and aims Rapid 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. Methods The 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. Discussion We 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 registration Streamline C ISRCTN43958015 (registered 25/7/2012). Streamline L ISRCTN50436483 (registered 31/7/2012).http://link.springer.com/article/10.1186/s12885-017-3281-xColorectal cancerLung cancerStagingComputed tomographyWhole body magnetic resonance imagingPositron emission tomography
spellingShingle Stuart A. Taylor
Sue Mallett
Anne Miles
Sandy Beare
Gauraang Bhatnagar
John Bridgewater
Rob Glynne-Jones
Vicky Goh
Ashley M. Groves
Sam M. Janes
Dow Mu Koh
Steve Morris
Alison Morton
Neal Navani
Alf Oliver
Anwar R. Padhani
Shonit Punwani
Andrea G. Rockall
Steve Halligan
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
Colorectal cancer
Lung cancer
Staging
Computed tomography
Whole body magnetic resonance imaging
Positron emission tomography
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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
topic Colorectal cancer
Lung cancer
Staging
Computed tomography
Whole body magnetic resonance imaging
Positron emission tomography
url http://link.springer.com/article/10.1186/s12885-017-3281-x
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