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<meta name="DC.Title" content="Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases." />
<meta name="DC.Date" content="1994-06-01" />
<meta name="DC.Publisher" content="American Journal of Neuroradiology" />
<meta name="DC.Rights" content="Copyright © American Society of Neuroradiology" />
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<meta name="DC.Description" content="PURPOSE To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.

METHODS We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.

RESULTS Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.

CONCLUSION Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis." />
<meta name="DC.Contributor" content="W T Yuh" />
<meta name="DC.Contributor" content="D J Fisher" />
<meta name="DC.Contributor" content="V M Runge" />
<meta name="DC.Contributor" content="S W Atlas" />
<meta name="DC.Contributor" content="S E Harms" />
<meta name="DC.Contributor" content="K R Maravilla" />
<meta name="DC.Contributor" content="N A Mayr" />
<meta name="DC.Contributor" content="J E Mollman" />
<meta name="DC.Contributor" content="A C Price" />
<meta name="article:published_time" content="1994-06-01" />
<meta name="citation_title" content="Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases." />
<meta name="citation_abstract" lang="en" content="&lt;h3&gt;PURPOSE&lt;/h3&gt;
&lt;p&gt;To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.&lt;/p&gt;&lt;h3&gt;METHODS&lt;/h3&gt;
&lt;p&gt;We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.&lt;/p&gt;&lt;h3&gt;RESULTS&lt;/h3&gt;
&lt;p&gt;Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.&lt;/p&gt;&lt;h3&gt;CONCLUSION&lt;/h3&gt;
&lt;p&gt;Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis.&lt;/p&gt;" />
<meta name="citation_journal_title" content="American Journal of Neuroradiology" />
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<meta name="citation_author" content="W T Yuh" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="D J Fisher" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="V M Runge" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="S W Atlas" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="S E Harms" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="K R Maravilla" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="citation_author" content="N A Mayr" />
<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
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<meta name="citation_author_institution" content="Department of Radiology, University of Iowa College of Medicine, Iowa City." />
<meta name="twitter:title" content="Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases." />
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<meta name="twitter:description" content="PURPOSE To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.

METHODS We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.

RESULTS Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.

CONCLUSION Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis." />
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<meta name="og-site-name" property="og:site_name" content="American Journal of Neuroradiology" />
<meta name="og-description" property="og:description" content="PURPOSE To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.

METHODS We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.

RESULTS Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.

CONCLUSION Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis." />
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      <h1 class="highwire-cite-title" id="page-title">Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases.</h1>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0">W T Yuh</span>, <span class="highwire-citation-author" data-delta="1">D J Fisher</span>, <span class="highwire-citation-author" data-delta="2">V M Runge</span>, <span class="highwire-citation-author" data-delta="3">S W Atlas</span>, <span class="highwire-citation-author" data-delta="4">S E Harms</span>, <span class="highwire-citation-author" data-delta="5">K R Maravilla</span>, <span class="highwire-citation-author" data-delta="6">N A Mayr</span>, <span class="highwire-citation-author" data-delta="7">J E Mollman</span> and <span class="highwire-citation-author" data-delta="8">A C Price</span></span></div>
  
    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">June 1994,  </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">15 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(6) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1037-1051; </span></div>
  
  
  
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<div id="hw-article-author-popups-top-node-6072--6919200235" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">W T Yuh </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'>Department of Radiology, University of Iowa College of Medicine, Iowa City.</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=W%2BT%2BYuh%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Yuh%20WT&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li class="author-site-search-link last"><a href="/search/author1%3AW%2BT%2BYuh%2B" rel="nofollow" class="" 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href="/search/author1%3AV%2BM%2BRunge%2B" rel="nofollow" class="" data-icon-position="" data-hide-link-title="0">Search for this author on this site</a></li></ul></div><div class="author-tooltip-3"><div class="author-tooltip-name">S W Atlas </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'>Department of Radiology, University of Iowa College of Medicine, Iowa City.</div></span></div><ul class="author-tooltip-find-more"><li class="author-tooltip-gs-link first"><a href="/lookup/google-scholar?link_type=googlescholar&amp;gs_type=author&amp;author%5B0%5D=S%2BW%2BAtlas%2B" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on Google Scholar</a></li><li class="author-tooltip-pubmed-link"><a href="/lookup/external-ref?access_num=Atlas%20SW&amp;link_type=AUTHORSEARCH" target="_blank" class="" data-icon-position="" data-hide-link-title="0">Find this author on PubMed</a></li><li 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          <p id="p-1"><strong>PURPOSE</strong> To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.</p>
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          <p id="p-2"><strong>METHODS</strong> We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.</p>
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          <p id="p-3"><strong>RESULTS</strong> Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.</p>
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          <p id="p-4"><strong>CONCLUSION</strong> Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis.</p>
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        	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-volume highwire-cite-metadata">Vol. 15</span>, <span  class="highwire-cite-metadata-issue highwire-cite-metadata">Issue 6 </span><div  class="highwire-cite-metadata-pubdate highwire-cite-metadata">1 Jun 1994 </div></div>
      
      
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      <div class="highwire-cite-title">Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases.</div>  
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    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Jun 1994, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">15 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(6) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1037-1051; </span></div>
  
  
  
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      <div class="highwire-cite-title">Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases.</div>  
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    	<div class="highwire-cite-metadata"><span  class="highwire-cite-metadata-journal highwire-cite-metadata">American Journal of Neuroradiology </span><span  class="highwire-cite-metadata-date highwire-cite-metadata">Jun 1994, </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">15 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(6) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">1037-1051; </span></div>
  
  
  
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