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Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study
BACKGROUND: Abdominal computed tomography (CT) is the standard imaging method for patients with suspected colorectal liver metastases (CRLM) in the diagnostic workup for surgery or thermal ablation. Diffusion-weighted and gadoxetic-acid-enhanced magnetic resonance imaging (MRI) of the liver is incre...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8524830/ https://www.ncbi.nlm.nih.gov/pubmed/34663243 http://dx.doi.org/10.1186/s12885-021-08833-1 |
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author | Görgec, B. Hansen, I. Kemmerich, G. Syversveen, T. Abu Hilal, M. Belt, E. J. T. Bisschops, R. H. C. Bollen, T. L. Bosscha, K. Burgmans, M. C. Cappendijk, V. De Boer, M. T. D’Hondt, M. Edwin, B. Gielkens, H. Grünhagen, D. J. Gillardin, P. Gobardhan, P. D. Hartgrink, H. H. Horsthuis, K. Kok, N. F. M. Kint, P. A. M. Kruimer, J. W. H. Leclercq, W. K. G. Lips, D. J. Lutin, B. Maas, M. Marsman, H. A. Morone, M. Pennings, J. P. Peringa, J. Te Riele, W. W. Vermaas, M. Wicherts, D. Willemssen, F. E. J. A. Zonderhuis, B. M. Bossuyt, P. M. M. Swijnenburg, R. J. Fretland, Å. A. Verhoef, C. Besselink, M. G. Stoker, J. |
author_facet | Görgec, B. Hansen, I. Kemmerich, G. Syversveen, T. Abu Hilal, M. Belt, E. J. T. Bisschops, R. H. C. Bollen, T. L. Bosscha, K. Burgmans, M. C. Cappendijk, V. De Boer, M. T. D’Hondt, M. Edwin, B. Gielkens, H. Grünhagen, D. J. Gillardin, P. Gobardhan, P. D. Hartgrink, H. H. Horsthuis, K. Kok, N. F. M. Kint, P. A. M. Kruimer, J. W. H. Leclercq, W. K. G. Lips, D. J. Lutin, B. Maas, M. Marsman, H. A. Morone, M. Pennings, J. P. Peringa, J. Te Riele, W. W. Vermaas, M. Wicherts, D. Willemssen, F. E. J. A. Zonderhuis, B. M. Bossuyt, P. M. M. Swijnenburg, R. J. Fretland, Å. A. Verhoef, C. Besselink, M. G. Stoker, J. |
author_sort | Görgec, B. |
collection | PubMed |
description | BACKGROUND: Abdominal computed tomography (CT) is the standard imaging method for patients with suspected colorectal liver metastases (CRLM) in the diagnostic workup for surgery or thermal ablation. Diffusion-weighted and gadoxetic-acid-enhanced magnetic resonance imaging (MRI) of the liver is increasingly used to improve the detection rate and characterization of liver lesions. MRI is superior in detection and characterization of CRLM as compared to CT. However, it is unknown how MRI actually impacts patient management. The primary aim of the CAMINO study is to evaluate whether MRI has sufficient clinical added value to be routinely added to CT in the staging of CRLM. The secondary objective is to identify subgroups who benefit the most from additional MRI. METHODS: In this international multicentre prospective incremental diagnostic accuracy study, 298 patients with primary or recurrent CRLM scheduled for curative liver resection or thermal ablation based on CT staging will be enrolled from 17 centres across the Netherlands, Belgium, Norway, and Italy. All study participants will undergo CT and diffusion-weighted and gadoxetic-acid enhanced MRI prior to local therapy. The local multidisciplinary team will provide two local therapy plans: first, based on CT-staging and second, based on both CT and MRI. The primary outcome measure is the proportion of clinically significant CRLM (CS-CRLM) detected by MRI not visible on CT. CS-CRLM are defined as liver lesions leading to a change in local therapeutical management. If MRI detects new CRLM in segments which would have been resected in the original operative plan, these are not considered CS-CRLM. It is hypothesized that MRI will lead to the detection of CS-CRLM in ≥10% of patients which is considered the minimal clinically important difference. Furthermore, a prediction model will be developed using multivariable logistic regression modelling to evaluate the predictive value of patient, tumor and procedural variables on finding CS-CRLM on MRI. DISCUSSION: The CAMINO study will clarify the clinical added value of MRI to CT in patients with CRLM scheduled for local therapy. This study will provide the evidence required for the implementation of additional MRI in the routine work-up of patients with primary and recurrent CRLM for local therapy. TRIAL REGISTRATION: The CAMINO study was registered in the Netherlands National Trial Register under number NL8039 on September 20th 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08833-1. |
format | Online Article Text |
id | pubmed-8524830 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-85248302021-10-22 Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study Görgec, B. Hansen, I. Kemmerich, G. Syversveen, T. Abu Hilal, M. Belt, E. J. T. Bisschops, R. H. C. Bollen, T. L. Bosscha, K. Burgmans, M. C. Cappendijk, V. De Boer, M. T. D’Hondt, M. Edwin, B. Gielkens, H. Grünhagen, D. J. Gillardin, P. Gobardhan, P. D. Hartgrink, H. H. Horsthuis, K. Kok, N. F. M. Kint, P. A. M. Kruimer, J. W. H. Leclercq, W. K. G. Lips, D. J. Lutin, B. Maas, M. Marsman, H. A. Morone, M. Pennings, J. P. Peringa, J. Te Riele, W. W. Vermaas, M. Wicherts, D. Willemssen, F. E. J. A. Zonderhuis, B. M. Bossuyt, P. M. M. Swijnenburg, R. J. Fretland, Å. A. Verhoef, C. Besselink, M. G. Stoker, J. BMC Cancer Study Protocol BACKGROUND: Abdominal computed tomography (CT) is the standard imaging method for patients with suspected colorectal liver metastases (CRLM) in the diagnostic workup for surgery or thermal ablation. Diffusion-weighted and gadoxetic-acid-enhanced magnetic resonance imaging (MRI) of the liver is increasingly used to improve the detection rate and characterization of liver lesions. MRI is superior in detection and characterization of CRLM as compared to CT. However, it is unknown how MRI actually impacts patient management. The primary aim of the CAMINO study is to evaluate whether MRI has sufficient clinical added value to be routinely added to CT in the staging of CRLM. The secondary objective is to identify subgroups who benefit the most from additional MRI. METHODS: In this international multicentre prospective incremental diagnostic accuracy study, 298 patients with primary or recurrent CRLM scheduled for curative liver resection or thermal ablation based on CT staging will be enrolled from 17 centres across the Netherlands, Belgium, Norway, and Italy. All study participants will undergo CT and diffusion-weighted and gadoxetic-acid enhanced MRI prior to local therapy. The local multidisciplinary team will provide two local therapy plans: first, based on CT-staging and second, based on both CT and MRI. The primary outcome measure is the proportion of clinically significant CRLM (CS-CRLM) detected by MRI not visible on CT. CS-CRLM are defined as liver lesions leading to a change in local therapeutical management. If MRI detects new CRLM in segments which would have been resected in the original operative plan, these are not considered CS-CRLM. It is hypothesized that MRI will lead to the detection of CS-CRLM in ≥10% of patients which is considered the minimal clinically important difference. Furthermore, a prediction model will be developed using multivariable logistic regression modelling to evaluate the predictive value of patient, tumor and procedural variables on finding CS-CRLM on MRI. DISCUSSION: The CAMINO study will clarify the clinical added value of MRI to CT in patients with CRLM scheduled for local therapy. This study will provide the evidence required for the implementation of additional MRI in the routine work-up of patients with primary and recurrent CRLM for local therapy. TRIAL REGISTRATION: The CAMINO study was registered in the Netherlands National Trial Register under number NL8039 on September 20th 2019. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08833-1. BioMed Central 2021-10-18 /pmc/articles/PMC8524830/ /pubmed/34663243 http://dx.doi.org/10.1186/s12885-021-08833-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Görgec, B. Hansen, I. Kemmerich, G. Syversveen, T. Abu Hilal, M. Belt, E. J. T. Bisschops, R. H. C. Bollen, T. L. Bosscha, K. Burgmans, M. C. Cappendijk, V. De Boer, M. T. D’Hondt, M. Edwin, B. Gielkens, H. Grünhagen, D. J. Gillardin, P. Gobardhan, P. D. Hartgrink, H. H. Horsthuis, K. Kok, N. F. M. Kint, P. A. M. Kruimer, J. W. H. Leclercq, W. K. G. Lips, D. J. Lutin, B. Maas, M. Marsman, H. A. Morone, M. Pennings, J. P. Peringa, J. Te Riele, W. W. Vermaas, M. Wicherts, D. Willemssen, F. E. J. A. Zonderhuis, B. M. Bossuyt, P. M. M. Swijnenburg, R. J. Fretland, Å. A. Verhoef, C. Besselink, M. G. Stoker, J. Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title | Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title_full | Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title_fullStr | Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title_full_unstemmed | Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title_short | Clinical added value of MRI to CT in patients scheduled for local therapy of colorectal liver metastases (CAMINO): study protocol for an international multicentre prospective diagnostic accuracy study |
title_sort | clinical added value of mri to ct in patients scheduled for local therapy of colorectal liver metastases (camino): study protocol for an international multicentre prospective diagnostic accuracy study |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8524830/ https://www.ncbi.nlm.nih.gov/pubmed/34663243 http://dx.doi.org/10.1186/s12885-021-08833-1 |
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