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)

Stuart A Taylor,Sue Mallett,Anne Miles,John Bridgewater,Rob Glynne-Jones,Alf Oliver,Vicky Goh,Steve Morris,Shonit Punwani,Steve Halligan,Alison Morton,Neal Navani,Sam M Janes,Andrea G Rockall,Anwar R Padhani,Ashley M Groves,Gauraang Bhatnagar,Sandy Beare,Dow Mu Koh

doi:10.1186/s12885-017-3281-x

Abstract

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).

Highlights

Background and aimsRapid and accurate cancer staging following diagnosis underpins patient management, in particular the identification of distant metastatic disease
A first major treatment decision is made by the multi-disciplinary team prior to WB-magnetic resonance imaging (MRI) revelation based on standard staging investigations only, based on the whole body magnetic resonance Imaging (WB-MRI) and any additional tests precipitated by WB-MRI, and based on all available test results
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

Summary

Introduction

Background and aimsRapid and accurate cancer staging following diagnosis underpins patient management, in particular the identification of distant metastatic disease. Lung and colorectal cancer are the second and third most common malignancies in the UK, each accounting for 16% of all new cancer diagnoses; approximately 87,000 patients diagnosed per year [1] Treatment decisions for both pivot on rapid and accurate tumour staging following diagnosis. The UK National Institute for Health and Care Excellence (NICE) guidelines outline an integrated but step-by-step sequential deployment of various imaging modalities before tumour staging is deemed complete and the first treatment decision is made [4] It is not unusual for a patient with colorectal cancer to undergo CT chest, abdomen and pelvis, together with pelvic MRI in the case of rectal cancer, with additional tests such as ultrasound, MRI and PET-CT used increasingly in cases of known or suspected metastatic disease. Patients receive significant doses of ionising radiation during the staging process that increase an individual’s risk of subsequent malignancy [5]

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