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. 2021 Oct 18;21(1):1116.
doi: 10.1186/s12885-021-08833-1.

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

B Görgec  1   2 , I Hansen  3   4 , G Kemmerich  5 , T Syversveen  5 , M Abu Hilal  6 , E J T Belt  7 , R H C Bisschops  8 , T L Bollen  9 , K Bosscha  10 , M C Burgmans  11 , V Cappendijk  12 , M T De Boer  13 , M D'Hondt  14 , B Edwin  3   4 , H Gielkens  15 , D J Grünhagen  16   17 , P Gillardin  18 , P D Gobardhan  19 , H H Hartgrink  20 , K Horsthuis  21 , N F M Kok  22 , P A M Kint  23 , J W H Kruimer  24 , W K G Leclercq  25 , D J Lips  26 , B Lutin  27 , M Maas  28 , H A Marsman  29 , M Morone  30 , J P Pennings  31 , J Peringa  32 , W W Te Riele  33 , M Vermaas  34 , D Wicherts  35 , F E J A Willemssen  36 , B M Zonderhuis  37 , P M M Bossuyt  38 , R J Swijnenburg  1   37 , Å A Fretland  3   4 , C Verhoef #  16   17 , M G Besselink #  1 , J Stoker #  39 ; CAMINO Study Group
Collaborators, Affiliations

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

B Görgec et al. BMC Cancer. .

Abstract

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.

Keywords: Abdominal CT scan; Colorectal cancer; Colorectal liver metastases; Diffusion weighted imaging; Gadoxetic acid; Hepatic resection; Liver MRI; Liver metastases; Liver surgery; Thermal ablation.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of study procedure during multidisciplinary team meeting
See this image and copyright information in PMC

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