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Randomized Controlled Trial
. 2014 May;101(6):613-21.
doi: 10.1002/bjs.9465. Epub 2014 Mar 20.

Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases

C J Zech  1 , P Korpraphong, A Huppertz, T Denecke, M J Kim, W Tanomkiat, E Jonas, A Ba-Ssalamah; VALUE study group
Collaborators, Affiliations
Free PMC article
Randomized Controlled Trial

Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases

C J Zech et al. Br J Surg. 2014 May.
Free PMC article

Abstract

Background: This multicentre international randomized trial compared the impact of gadoxetic acid-enhanced magnetic resonance imaging (MRI), MRI with extracellular contrast medium (ECCM-MRI) and contrast-enhanced computed tomography (CE-CT) as a first-line imaging method in patients with suspected colorectal cancer liver metastases (CRCLM).

Methods: Between October 2008 and September 2010, patients with suspected CRCLM were randomized to one of the three imaging modalities. The primary endpoint was the proportion of patients for whom further imaging after initial imaging was required for a confident diagnosis. Secondary variables included confidence in the therapeutic decision, intraoperative deviations from the initial imaging-based surgical plan as a result of additional operative findings, and diagnostic efficacy of the imaging modalities versus intraoperative and pathological extent of the disease.

Results: A total of 360 patients were enrolled. Efficacy was analysed in 342 patients (118, 112 and 112 with gadoxetic acid-enhanced MRI, ECCM-MRI and CE-CT respectively as the initial imaging procedure). Further imaging was required in 0 of 118, 19 (17.0 per cent) of 112 and 44 (39.3 per cent) of 112 patients respectively (P < 0.001). Diagnostic confidence was high or very high in 98.3 per cent of patients for gadoxetic acid-enhanced MRI, 85.7 per cent for ECCM-MRI and 65.2 per cent for CE-CT. Surgical plans were changed during surgery in 28, 32 and 47 per cent of patients in the respective groups.

Conclusion: The diagnostic performance of gadoxetic acid-enhanced MRI was better than that of CE-CT and ECCM-MRI as the initial imaging modality. No further imaging was needed in the gadoxetic acid-enhanced MRI group and comparison of diagnostic efficacy parameters demonstrated the diagnostic superiority of gadoxetic acid-enhanced MRI.

Registration number: NCT00764621(http://clinicaltrials.gov); EudraCT number: 2008-000583-16 (https://eudract.ema.europa.eu/).

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Figure 1
Figure 1
Flow diagram of patients randomized to initial imaging using gadoxetic acid-enhanced magnetic resonance imaging (MRI), MRI with extracellular contrast media (ECCM-MRI) or contrast-enhanced computed tomography (CE-CT). *The 12 major protocol violations occurred in four patients who had a second imaging procedure and in eight patients who did not have a second imaging procedure
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References

    1. Adam R, De Gramont A, Figueras J, Guthrie A, Kokudo N, Kunstlinger F, et al. Jean-Nicolas Vauthey of the EGOSLIM (Expert Group on OncoSurgery management of LIver Metastases) group. The oncosurgery approach to managing liver metastases from colorectal cancer: a multidisciplinary international consensus. Oncologist. 2012;17:1225–1239. - PMC - PubMed
    1. Ballantyne GH, Quin J. Surgical treatment of liver metastases in patients with colorectal cancer. Cancer. 1993;71(Suppl):4252–4266. - PubMed
    1. Bengtsson G, Carlsson G, Hafstrom L, Jonsson PE. Natural history of patients with untreated liver metastases from colorectal cancer. Am J Surg. 1981;141:586–589. - PubMed
    1. Wald C, Scheirey CD, Tran TM, Erbay N. An update on imaging of colorectal cancer. Surg Clin North Am. 2006;86:819–847. - PubMed
    1. Scheer A, Auer RA. Surveillance after curative resection of colorectal cancer. Clin Colon Rectal Surg. 2009;22:242–250. - PMC - PubMed

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