Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases
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 co...
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| Veröffentlicht in: | British journal of surgery 2014-05, Vol.101 (6), p.613-621 |
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| creator | Zech, C. J. Korpraphong, P. Huppertz, A. Denecke, T. Kim, M.-J. Tanomkiat, W. Jonas, E. Ba-Ssalamah, A. |
| description | 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 |
| doi_str_mv | 10.1002/bjs.9465 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_swepu</sourceid><recordid>TN_cdi_swepub_primary_oai_swepub_ki_se_522818</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3270885911</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4475-5d2cf4bad71898d3d2b2034985420ec983a4ef8edc5181607766a3189666d2673</originalsourceid><addsrcrecordid>eNpdks1uEzEQx1cIRENB4gmQJS5ctvh7vRckEkEpSkEqRUhcLMc7SZzu2sXeTVsegmfGS0NKOY0185v_fHiK4jnBRwRj-nqxSUc1l-JBMSFMipISqR4WE4xxVRJG2UHxJKUNxoRhQR8XBzSzVNZ4Uvw6M74JnfsJDeqGtncWfB8B9dGZFoUlWpkmXEP2I2NdU4JfG28zfHp2grYQ05CQDX6bs1zwOWX0h4hm58h51K8Bpd6snF-NWja0IYLtM2ZHlYhalzVQB73JWIL0tHi0NG2CZzt7WHx9_-589qGcfz4-mb2dl5bzSpSioXbJF6apiKpVwxq6oJjxWglOMdhaMcNhqaCxgigicVVJaVhmpZQNlRU7LMpb3XQFl8NCX0bXmXijg3F657rIL9CCUkVU5t_c8jnSZdlxSaa9l3Y_4t1ar8JWc0ZoTUgWeLUTiOHHAKnXnUsW2tZ4CEPSRBAhOSFirPXyP3QThph3-4fKA3JFWKZe_NvRvpW_X3s34pVr4WYfJ1iPJ6PzyejxZPT045fR3vEu9XC950280HlhldDfPh3r-XRW0-9yqk_Zbwtew_U</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1514204813</pqid></control><display><type>article</type><title>Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>SWEPUB Freely available online</source><creator>Zech, C. J. ; Korpraphong, P. ; Huppertz, A. ; Denecke, T. ; Kim, M.-J. ; Tanomkiat, W. ; Jonas, E. ; Ba-Ssalamah, A.</creator><creatorcontrib>Zech, C. J. ; Korpraphong, P. ; Huppertz, A. ; Denecke, T. ; Kim, M.-J. ; Tanomkiat, W. ; Jonas, E. ; Ba-Ssalamah, A. ; VALUE study group</creatorcontrib><description>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/).
Gadoxetic acid‐enhanced MRI is better</description><identifier>ISSN: 0007-1323</identifier><identifier>EISSN: 1365-2168</identifier><identifier>DOI: 10.1002/bjs.9465</identifier><identifier>PMID: 24652690</identifier><identifier>CODEN: BJSUAM</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms ; Contrast Media ; Female ; Gadolinium DTPA ; Humans ; Liver Neoplasms - diagnostic imaging ; Liver Neoplasms - pathology ; Liver Neoplasms - secondary ; Liver Neoplasms - surgery ; Magnetic Resonance Imaging - methods ; Male ; Middle Aged ; Neoplasm Staging - methods ; Patient Care Planning ; Randomized Clinical Trial ; Sensitivity and Specificity ; Tomography, X-Ray Computed - methods ; Treatment Outcome</subject><ispartof>British journal of surgery, 2014-05, Vol.101 (6), p.613-621</ispartof><rights>2014 The Authors. published by John Wiley & Sons Ltd on behalf of BJS Society Ltd</rights><rights>2014 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.</rights><rights>2014 BJS Society Ltd. Published by John Wiley & Sons Ltd</rights><rights>2014 The Authors. published by John Wiley & Sons Ltd on behalf of BJS Society Ltd 2014</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4475-5d2cf4bad71898d3d2b2034985420ec983a4ef8edc5181607766a3189666d2673</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fbjs.9465$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fbjs.9465$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,550,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24652690$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:128841486$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Zech, C. J.</creatorcontrib><creatorcontrib>Korpraphong, P.</creatorcontrib><creatorcontrib>Huppertz, A.</creatorcontrib><creatorcontrib>Denecke, T.</creatorcontrib><creatorcontrib>Kim, M.-J.</creatorcontrib><creatorcontrib>Tanomkiat, W.</creatorcontrib><creatorcontrib>Jonas, E.</creatorcontrib><creatorcontrib>Ba-Ssalamah, A.</creatorcontrib><creatorcontrib>VALUE study group</creatorcontrib><title>Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases</title><title>British journal of surgery</title><addtitle>Br J Surg</addtitle><description>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/).
Gadoxetic acid‐enhanced MRI is better</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Colorectal Neoplasms</subject><subject>Contrast Media</subject><subject>Female</subject><subject>Gadolinium DTPA</subject><subject>Humans</subject><subject>Liver Neoplasms - diagnostic imaging</subject><subject>Liver Neoplasms - pathology</subject><subject>Liver Neoplasms - secondary</subject><subject>Liver Neoplasms - surgery</subject><subject>Magnetic Resonance Imaging - methods</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Neoplasm Staging - methods</subject><subject>Patient Care Planning</subject><subject>Randomized Clinical Trial</subject><subject>Sensitivity and Specificity</subject><subject>Tomography, X-Ray Computed - methods</subject><subject>Treatment Outcome</subject><issn>0007-1323</issn><issn>1365-2168</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><sourceid>D8T</sourceid><recordid>eNpdks1uEzEQx1cIRENB4gmQJS5ctvh7vRckEkEpSkEqRUhcLMc7SZzu2sXeTVsegmfGS0NKOY0185v_fHiK4jnBRwRj-nqxSUc1l-JBMSFMipISqR4WE4xxVRJG2UHxJKUNxoRhQR8XBzSzVNZ4Uvw6M74JnfsJDeqGtncWfB8B9dGZFoUlWpkmXEP2I2NdU4JfG28zfHp2grYQ05CQDX6bs1zwOWX0h4hm58h51K8Bpd6snF-NWja0IYLtM2ZHlYhalzVQB73JWIL0tHi0NG2CZzt7WHx9_-589qGcfz4-mb2dl5bzSpSioXbJF6apiKpVwxq6oJjxWglOMdhaMcNhqaCxgigicVVJaVhmpZQNlRU7LMpb3XQFl8NCX0bXmXijg3F657rIL9CCUkVU5t_c8jnSZdlxSaa9l3Y_4t1ar8JWc0ZoTUgWeLUTiOHHAKnXnUsW2tZ4CEPSRBAhOSFirPXyP3QThph3-4fKA3JFWKZe_NvRvpW_X3s34pVr4WYfJ1iPJ6PzyejxZPT045fR3vEu9XC950280HlhldDfPh3r-XRW0-9yqk_Zbwtew_U</recordid><startdate>201405</startdate><enddate>201405</enddate><creator>Zech, C. J.</creator><creator>Korpraphong, P.</creator><creator>Huppertz, A.</creator><creator>Denecke, T.</creator><creator>Kim, M.-J.</creator><creator>Tanomkiat, W.</creator><creator>Jonas, E.</creator><creator>Ba-Ssalamah, A.</creator><general>John Wiley & Sons, Ltd</general><general>Oxford University Press</general><scope>BSCLL</scope><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope></search><sort><creationdate>201405</creationdate><title>Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases</title><author>Zech, C. J. ; Korpraphong, P. ; Huppertz, A. ; Denecke, T. ; Kim, M.-J. ; Tanomkiat, W. ; Jonas, E. ; Ba-Ssalamah, A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4475-5d2cf4bad71898d3d2b2034985420ec983a4ef8edc5181607766a3189666d2673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Colorectal Neoplasms</topic><topic>Contrast Media</topic><topic>Female</topic><topic>Gadolinium DTPA</topic><topic>Humans</topic><topic>Liver Neoplasms - diagnostic imaging</topic><topic>Liver Neoplasms - pathology</topic><topic>Liver Neoplasms - secondary</topic><topic>Liver Neoplasms - surgery</topic><topic>Magnetic Resonance Imaging - methods</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Neoplasm Staging - methods</topic><topic>Patient Care Planning</topic><topic>Randomized Clinical Trial</topic><topic>Sensitivity and Specificity</topic><topic>Tomography, X-Ray Computed - methods</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zech, C. J.</creatorcontrib><creatorcontrib>Korpraphong, P.</creatorcontrib><creatorcontrib>Huppertz, A.</creatorcontrib><creatorcontrib>Denecke, T.</creatorcontrib><creatorcontrib>Kim, M.-J.</creatorcontrib><creatorcontrib>Tanomkiat, W.</creatorcontrib><creatorcontrib>Jonas, E.</creatorcontrib><creatorcontrib>Ba-Ssalamah, A.</creatorcontrib><creatorcontrib>VALUE study group</creatorcontrib><collection>Istex</collection><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SwePub Articles full text</collection><jtitle>British journal of surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zech, C. J.</au><au>Korpraphong, P.</au><au>Huppertz, A.</au><au>Denecke, T.</au><au>Kim, M.-J.</au><au>Tanomkiat, W.</au><au>Jonas, E.</au><au>Ba-Ssalamah, A.</au><aucorp>VALUE study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases</atitle><jtitle>British journal of surgery</jtitle><addtitle>Br J Surg</addtitle><date>2014-05</date><risdate>2014</risdate><volume>101</volume><issue>6</issue><spage>613</spage><epage>621</epage><pages>613-621</pages><issn>0007-1323</issn><eissn>1365-2168</eissn><coden>BJSUAM</coden><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/).
Gadoxetic acid‐enhanced MRI is better</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>24652690</pmid><doi>10.1002/bjs.9465</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of surgery, 2014-05, Vol.101 (6), p.613-621 |
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| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Wiley Online Library Journals Frontfile Complete; SWEPUB Freely available online |
| subjects | Adult Aged Aged, 80 and over Colorectal Neoplasms Contrast Media Female Gadolinium DTPA Humans Liver Neoplasms - diagnostic imaging Liver Neoplasms - pathology Liver Neoplasms - secondary Liver Neoplasms - surgery Magnetic Resonance Imaging - methods Male Middle Aged Neoplasm Staging - methods Patient Care Planning Randomized Clinical Trial Sensitivity and Specificity Tomography, X-Ray Computed - methods Treatment Outcome |
| title | Randomized multicentre trial of gadoxetic acid-enhanced MRI versus conventional MRI or CT in the staging of colorectal cancer liver metastases |
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