1. Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed colorectal cancer: the prospective Streamline C trial
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Vicky Goh, Alistair Rienhardt, Priya Limbu, Veronica A. Morgan, Beth Shepherd, David J. Breen, Kayleigh Gilbert, Paul Nichols, Lisa Woodrow, Neal Navani, Sophia Hans, Stephen Karp, Ruth E.C. Evans, Chris Everitt, Andrew Gogbashian, Elizabeth Chang, Nina Tunariu, Amelia Daniel, Elizabeth Hadley, Tina Mills-Baldock, Clare Collins, Ibiyemi Olaleye, Shraddha Weir, Martha Handousa, Rob Glynne-Jones, Steve Halligan, Antony Higginson, Uday Patel, Azmina Verjee, Aji Kavidasan, Sarah Howling, Andrew Bateman, Priscilla Phiri, Imogen Locke, Lyn Blakeway, Joanne Kellaway, Abel Jalloh, Elizabeth Green, Helen Pardoe, Simon Ball, Reyes Lauigan, Jonathan Wilson, Dominic Blunt, U. Ekeowa, Amy Davis, Jon Robinson, S. Burke, Prital Patel, Marian Duggan, Harbir S. Sidhu, Farzana Rahman, Sofia Gourtsoyianni, Shaki Balogun, Pippa Riddle, Peter Boavida, Colin Elton, Stefania Stegner, Daniel J. Smith, Zoltan Nagy, Suzanne Chukundah, Jenna Couture, Laura L. Quinn, Terry O'Shaughnessy, Revanth Jannapureddy, Heather Hughes, Shonit Punwani, Subramanian Ramesh, Anne Miles, Sajid A. Khan, Michelle Saull, Stuart A. Taylor, Tanjil Nawaz, Khawaja Shahabuddin, Andy Lowe, Gauraang Bhatnagar, James Crosbie, Thida Win, Rashidat Adeniba, Helen Beedham, Sahar Naaseri, Nicola Lucas, Fiona McKirdy, Abby Sharp, Lorraine Hurl, Nicola Gibbons, Laura Hughes, Alison Morton, William Partridge, Amy Smith, Krystyna Reczko, Rudi Borgstein, Ann O'Callaghan, Davide Prezzi, Ayshea Hameeduddin, Nelesh Jeyadevan, Matthew Train, John O'Donohue, Teresa Light, Shahanara Ferdous, Austen Obichere, Caroline S. Clarke, Wivijin Piga, Anita Rhodes, Ian C Simcock, Meena Reddi, Shanna Wilson, John Bridgewater, Keyury Desai, Anwar R. Padhani, Maureen Furneaux, Raj Srirajaskanthan, Kishor Barhate, Anita Amadi, Sandy Beare, Dorothee Boisfer, Ferrial Syeed, Elizabeth Isaac, Amjad Mohammed, Katie Prior, Mohamed A. Thaha, Jonathan McCullogh, Kara Sargus, Andrea Rockall, Clive Kay, David Chao, Eleni Ntala, J. James Stirling, Dow-Mu Koh, David Birch, Adrian Green, Marie Jackson, Sanjaya Wijeyekoon, Girija Anand, Hameed Rafiee, Ali Mohammed, Richard Beable, William Ricketts, Liane Davis, Shafi Ahmed, Tina Stoycheva, Sally O'Connor, Jamila Roehrig, Steve Ellis, Catherine Norman, Balinder Hans, Nishat Bharwani, Peter Russell, Kitrick Perry, Ellice Marwood, Alfred Oliver, Stephen Morris, Veronica Conteh, Eleni Karapanagiotou, Saba Mahmud, Sidra Tulmuntaha, Christian Kelly-Morland, Alice Johnson, Sasithar Maheswaran, Farid Bazari, Yvonne Campbell, Rajapandian Ilangovan, Adnam Alam, Tuck-Kay Loke, Susan Mallett, G. Atkin, Nicola H. Strickland, Dominic Yu, Ashley M. Groves, Chloe van Someren, Ian Jenkins, Kai-Keen Shiu, Colm Prendergast, Sherif Raouf, Jagadish Kalasthry, David Snell, Nathalie Rich, Louise Lim, Michael Long, Edward W. Johnston, Kathryn Tarver, Sam M. Janes, Laletha Agoramoorthy, Rommel Butawan, Pooja Datt, Jonathan Teague, Christopher Wanstall, Jane De Los, Sara Lock, Adoracion Jayme, Alec Engledow, Janet McGowan, Andre Nunes, Akosa Aboagye, Howard Curtis, Teresita Beeston, Angshu Bhowmik, Gule Hanid, E. Scurr, Payal Julka, Lesley Honeyfield, Aileen Austria, Celia Simeon, Katherine van Ree, Adesewa Onajobi, Lara Curry, Imperial College Healthcare NHS Trust- BRC Funding, and Department of Health
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Male ,medicine.medical_specialty ,Technology Assessment, Biomedical ,Colorectal cancer ,Population ,Streamline investigators ,Sensitivity and Specificity ,Article ,law.invention ,Metastasis ,psyc ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Humans ,Whole Body Imaging ,Prospective Studies ,Neoplasm Metastasis ,Adverse effect ,education ,Prospective cohort study ,Aged ,Neoplasm Staging ,education.field_of_study ,Pregnancy ,Hepatology ,business.industry ,Gastroenterology ,Cancer ,Neoplasms, Second Primary ,Middle Aged ,Reference Standards ,medicine.disease ,Magnetic Resonance Imaging ,3. Good health ,030220 oncology & carcinogenesis ,Critical Pathways ,Female ,030211 gastroenterology & hepatology ,Colorectal Neoplasms ,business - Abstract
BACKGROUND: 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.METHODS: 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.FINDINGS: 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.INTERPRETATION: WB-MRI staging pathways have similar accuracy to standard pathways and reduce the number of tests needed, staging time, and cost.FUNDING: UK National Institute for Health Research.
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- 2019