Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed colorectal cancer: the prospective Streamline C trial
Authors: Stuart A Taylor, Sue Mallett, Sandy Beare, Gauraang Bhatnagar, Dominic Blunt, Peter Boavida, John Bridgewater, Caroline S Clarke, Marian Duggan, Steve Ellis, Robert Glynne-Jones, Vicky Goh, Ashley M Groves, Ayshea Hameeduddin, Sam M Janes, Edward W Johnston, Dow-Mu Koh, Anne Miles, Stephen Morris, Alison Morton, Neal Navani, John O'Donohue, Alfred Oliver, Anwar R Padhani, Helen Pardoe, Uday Patel, Shonit Punwani, Laura Quinn, Hameed Rafiee, Krystyna Reczko, Andrea G Rockall, Khawaja Shahabuddin, Harbir S Sidhu, Jonathan Teague, Mohamed A Thaha, Matthew Train, Katherine van Ree, Sanjaya Wijeyekoon, Steve Halligan, Ruth Evans, Simon Ball, Revanth Jannapureddy, Tina Mills-Baldock, Kishor Barhate, Zoltan Nagy, Sherif Raouf, Akosa Aboagye, Girija Anand, Rommel Butawan, Elizabeth Hadley, Adesewa Onajobi, Kathryn Tarver, Tanjil Nawaz, Catherine Norman, Nathalie Rich, Sidra Tulmuntaha, Shafi Ahmed, Louise Lim, Fiona McKirdy, Jenna Couture, Shahanara Ferdous, Payal Julka, Ali Mohammed, Terry O'Shaughnessy, William Ricketts, Marie Jackson, Clive Kay, Andy Lowe, Janet McGowan, Amjad Mohammed, Jon Robinson, Lara Curry, Sasithar Maheswaran, Subramanian Ramesh, Pippa Riddle, Shaki Balogun, Yvonne Campbell, Nelesh Jeyadevan, Aji Kavidasan, Imogen Locke, Tuck-Kay Loke, Ibiyemi Olaleye, Clare Collins, Elizabeth Green, Colm Prendergast, Thida Win, Amy Davis, Lyn Blakeway, Sofia Gourtsoyianni, Adrian Green, Christian Kelly-Morland, Sahar Naaseri, Davide Prezzi, David Snell, Dorothee Boisfer, Keyury Desai, Balinder Hans, Sophia Hans, Eleni Ntala, Adnam Alam, Stephen Burke, Angshu Bhowmik, Nishat Bharwani, Gule Hanid, Lesley Honeyfield, Tina Stoycheva, Nicola Strickland, Farid Bazari, Helen Beedham, Jane De Los, Reyes Lauigan, Priya Limbu, Nicola Lucas, Sally O'Connor, Anita Rhodes, Laletha Agoramoorthy, Martha Handousa, Abel Jalloh, Stefania Stegner, Shanna Wilson, David Birch, Suzanne Chukundah, Priscilla Phiri, Raj Srirajaskanthan, Eleni Karapanagiotou, Daniel Smith, Ferrial Syeed, Chloe van Someren, Rudi Borgstein, Jamila Roehrig, David Chao, Lorraine Hurl, Andrew Gogbashian, Andre Nunes, Ian Simcock, James Stirling, Richard Beable, Maureen Furneaux, Nicola Gibbons, Antony Higginson, Howard Curtis, Kitrick Perry, Anita Amadi, Heather Hughes, Prital Patel, Gary Atkin, Colin Elton, Stephen Karp, Lisa Woodrow, Dominic Yu, Sajid Khan, Alistair Rienhardt, Pooja Datt, Rajapandian Ilangovan, Ian Jenkins, Saba Mahmud, Teresa Light, Joanne Kellaway, Ann O'Callaghan, William Partridge, Amelia Daniel, Ugo Ekeowa, Michael Long, Peter Russell, Erica Scurr, Veronica Morgan, Nina Tunariu, Elizabeth Chang, Laura Hughes, Ellice Marwood, Katie Prior, Meena Reddi, Kara Sargus, Abby Sharp, Teresita Beeston, Elizabeth Isaac, Adoracion Jayme, Jagadish Kalasthry, Wivijin Piga, Farzana Rahman, Shraddha Weir, Aileen Austria, James Crosbie, Alec Engledow, Jonathan McCullogh, Austen Obichere, Kai-Keen Shiu, Christopher Wanstall, Celia Simeon, Amy Smith, Andrew Bateman, David Breen, Liane Davis, Chris Everitt, Alice Johnson, Paul Nichols, Beth Shepherd, Kayleigh Gilbert, Azmina Verjee, Michelle Saull, Jonathan Wilson, Rashidat Adeniba, Veronica Conteh, Sarah Howling, Sara Lock
Journal: The Lancet. Gastroenterology & hepatology (2019)

<h2>Summary</h2><h3>Background</h3> Whole-body MRI (WB-MRI) could be an alternative to multimodality staging of colorectal cancer, but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in colorectal cancer. <h3>Methods</h3> The Streamline C trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed colorectal cancer. Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN43958015, and is complete. <h3>Findings</h3> Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility. 370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline. Pathway sensitivity was 67% (95% CI 56 to 78) for WB-MRI and 63% (51 to 74) for standard pathways, a difference in sensitivity of 4% (−5 to 13, p=0·51). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (95% [95% CI 92–97]) and standard pathways (93% [90–96], p=0·48). Agreement with the multidisciplinary team's final treatment decision was 96% for WB-MRI and 95% for the standard pathway. Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6–9]) than for the standard pathway (13 days [11–15]); a 5-day (3–7) difference. WB-MRI required fewer tests (median, one [95% CI 1 to 1]) than did standard pathways (two [2 to 2]), a difference of one (1 to 1). Mean per-patient staging costs were £216 (95% CI 211–221) for WB-MRI and £285 (260–310) for standard pathways. <h3>Interpretation</h3> WB-MRI staging pathways have similar accuracy to standard pathways and reduce the number of tests needed, staging time, and cost. <h3>Funding</h3> UK National Institute for Health Research.