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1. Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed colorectal cancer: the prospective Streamline C trial

Author

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

Subjects
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.

Published
2019

2. Diagnostic accuracy of whole-body MRI versus standard imaging pathways for metastatic disease in newly diagnosed non-small-cell lung cancer: the prospective Streamline L trial

Author

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

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, Lung Neoplasms, Population, Disease, Streamline investigators, Sensitivity and Specificity, 030218 nuclear medicine & medical imaging, Metastasis, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Whole Body Imaging, Prospective Studies, Neoplasm Metastasis, education, Lung cancer, Adverse effect, Lung, Aged, education.field_of_study, Pregnancy, medicine.diagnostic_test, business.industry, Magnetic resonance imaging, Middle Aged, medicine.disease, Magnetic Resonance Imaging, 3. Good health, England, 030220 oncology & carcinogenesis, Female, Radiology, business, Tomography, X-Ray Computed
Abstract

Summary Background Whole-body magnetic resonance imaging (WB-MRI) could be an alternative to multi-modality staging of non-small-cell lung cancer (NSCLC), 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 NSCLC. Methods The Streamline L trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed NSCLC that was potentially radically treatable on diagnostic chest CT (defined as stage IIIb or less). Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or histologies other than NSCLC. 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 ISRCTN50436483, and is complete. Findings Between Feb 26, 2013, and Sept 5, 2016, 976 patients were screened for eligibility. 353 patients were recruited, 187 of whom completed the trial; 52 (28%) had metastasis at baseline. Pathway sensitivity was 50% (95% CI 37–63) for WB-MRI and 54% (41–67) for standard pathways, a difference of 4% (−7 to 15, p=0·73). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (93% [88–96]) and standard pathways (95% [91–98], p=0·45). Agreement with the multidisciplinary team's final treatment decision was 98% for WB-MRI and 99% for the standard pathway. Time to complete staging was shorter for WB-MRI (13 days [12–14]) than for the standard pathway (19 days [17–21]); a 6-day (4–8) difference. The number of tests required was similar WB-MRI (one [1–1]) and standard pathways (one [1–2]). Mean per-patient costs were £317 (273–361) for WBI-MRI and £620 (574–666) for standard pathways. Interpretation WB-MRI staging pathways have similar accuracy to standard pathways, and reduce the staging time and costs. Funding UK National Institute for Health Research.

Published
2019

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