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<meta name="DC.Description" content="A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Although safety data were complete in all 88 cases, only 83 had valid efficacy data (57 received Gd-DTPA, 26 placebo). Three patients were excluded from efficacy evaluation because of incomplete scans or scans with severe motion artifacts. Two patients were excluded for protocol variations (did not have a mass lesion). The protocol required that spin-echo MR images be acquired both before and after infusion at mode 1, 500/30/2 (TR/TE/excitations), and at a single-echo mode 2 sequence within a selected range, 1500-2000/56-90/2. Additional TEs could also be used at the discretion of each investigator. Efficacy was determined by comparing post- with preinjection images for relative degree of enhancement and improvement of diagnostic ability after injection, and by comparing these results with placebo results. Enhancement was reported in 43 (75%) of 57 Gd-DTPA patients and in none of the 26 placebo patients. Improvement of diagnostic ability was noted in 37 of 57 Gd-DTPA patients and in no placebo patients. Of 17 patients receiving Gd-DTPA for whom no diagnosis could be made before infusion, nine of 17 were diagnosed after infusion. By comparison, none of five patients not diagnosed before infusion of placebo could be diagnosed after infusion. Of 43 patients in whom lesion enhancement was observed after Gd-DTPA infusion, the diagnosis changed after infusion in 16 (37%) and the number of lesions detected after infusion increased in 10 (23%). Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients.

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<meta name="citation_abstract" lang="en" content="&lt;p&gt;A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Although safety data were complete in all 88 cases, only 83 had valid efficacy data (57 received Gd-DTPA, 26 placebo). Three patients were excluded from efficacy evaluation because of incomplete scans or scans with severe motion artifacts. Two patients were excluded for protocol variations (did not have a mass lesion). The protocol required that spin-echo MR images be acquired both before and after infusion at mode 1, 500/30/2 (TR/TE/excitations), and at a single-echo mode 2 sequence within a selected range, 1500-2000/56-90/2. Additional TEs could also be used at the discretion of each investigator. Efficacy was determined by comparing post- with preinjection images for relative degree of enhancement and improvement of diagnostic ability after injection, and by comparing these results with placebo results. Enhancement was reported in 43 (75%) of 57 Gd-DTPA patients and in none of the 26 placebo patients. Improvement of diagnostic ability was noted in 37 of 57 Gd-DTPA patients and in no placebo patients. Of 17 patients receiving Gd-DTPA for whom no diagnosis could be made before infusion, nine of 17 were diagnosed after infusion. By comparison, none of five patients not diagnosed before infusion of placebo could be diagnosed after infusion. Of 43 patients in whom lesion enhancement was observed after Gd-DTPA infusion, the diagnosis changed after infusion in 16 (37%) and the number of lesions detected after infusion increased in 10 (23%). Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients.&lt;/p&gt;&lt;p&gt;This study confirms that Gd-DTPA is an efficacious contrast agent for use with MR and that it exhibits excellent patient tolerance. Enhancement allows for a decisive diagnosis to be made in selected cases in which such capability had previously been lacking with unenhanced MR.&lt;/p&gt;" />
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<meta name="twitter:description" content="A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Although safety data were complete in all 88 cases, only 83 had valid efficacy data (57 received Gd-DTPA, 26 placebo). Three patients were excluded from efficacy evaluation because of incomplete scans or scans with severe motion artifacts. Two patients were excluded for protocol variations (did not have a mass lesion). The protocol required that spin-echo MR images be acquired both before and after infusion at mode 1, 500/30/2 (TR/TE/excitations), and at a single-echo mode 2 sequence within a selected range, 1500-2000/56-90/2. Additional TEs could also be used at the discretion of each investigator. Efficacy was determined by comparing post- with preinjection images for relative degree of enhancement and improvement of diagnostic ability after injection, and by comparing these results with placebo results. Enhancement was reported in 43 (75%) of 57 Gd-DTPA patients and in none of the 26 placebo patients. Improvement of diagnostic ability was noted in 37 of 57 Gd-DTPA patients and in no placebo patients. Of 17 patients receiving Gd-DTPA for whom no diagnosis could be made before infusion, nine of 17 were diagnosed after infusion. By comparison, none of five patients not diagnosed before infusion of placebo could be diagnosed after infusion. Of 43 patients in whom lesion enhancement was observed after Gd-DTPA infusion, the diagnosis changed after infusion in 16 (37%) and the number of lesions detected after infusion increased in 10 (23%). Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients.

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<meta name="og-description" property="og:description" content="A multicenter double-blind randomized study was designed to evaluate and compare the safety and diagnostic efficacy of gadopentetate dimeglumine (Gd-DTPA) (0.1 mmol/kg) against a saline placebo for use as an IV contrast agent for MR. The randomization code provided for a 2:1 ratio of Gd-DTPA and saline patients. Six investigators studied 88 patients with signs and symptoms of a cerebral lesion. Although safety data were complete in all 88 cases, only 83 had valid efficacy data (57 received Gd-DTPA, 26 placebo). Three patients were excluded from efficacy evaluation because of incomplete scans or scans with severe motion artifacts. Two patients were excluded for protocol variations (did not have a mass lesion). The protocol required that spin-echo MR images be acquired both before and after infusion at mode 1, 500/30/2 (TR/TE/excitations), and at a single-echo mode 2 sequence within a selected range, 1500-2000/56-90/2. Additional TEs could also be used at the discretion of each investigator. Efficacy was determined by comparing post- with preinjection images for relative degree of enhancement and improvement of diagnostic ability after injection, and by comparing these results with placebo results. Enhancement was reported in 43 (75%) of 57 Gd-DTPA patients and in none of the 26 placebo patients. Improvement of diagnostic ability was noted in 37 of 57 Gd-DTPA patients and in no placebo patients. Of 17 patients receiving Gd-DTPA for whom no diagnosis could be made before infusion, nine of 17 were diagnosed after infusion. By comparison, none of five patients not diagnosed before infusion of placebo could be diagnosed after infusion. Of 43 patients in whom lesion enhancement was observed after Gd-DTPA infusion, the diagnosis changed after infusion in 16 (37%) and the number of lesions detected after infusion increased in 10 (23%). Safety studies showed no clinically significant abnormal trends. Minor changes in blood pressure, pulse, and serum iron levels were noted in a higher percentage of Gd-DTPA patients.

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      <h1 class="highwire-cite-title" id="page-title">Multicenter Double-Blind Placebo-Controlled Study of Gadopentetate Dimeglumine as an MR Contrast Agent: Evaluation in Patients with Cerebral Lesions</h1>  
    	<div class="highwire-cite-authors"><span  class="highwire-citation-authors"><span class="highwire-citation-author first" data-delta="0">Eric J. Russell</span>, <span class="highwire-citation-author" data-delta="1">Thomas F. Schaible</span>, <span class="highwire-citation-author" data-delta="2">William Dillon</span>, <span class="highwire-citation-author" data-delta="3">Burton Drayer</span>, <span class="highwire-citation-author" data-delta="4">Joseph LiPuma</span>, <span class="highwire-citation-author" data-delta="5">Anthony Mancuso</span>, <span class="highwire-citation-author" data-delta="6">Kenneth Maravilla</span> and <span class="highwire-citation-author" data-delta="7">Harold A. Goldstein</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">January 1989,  </span><span  class="highwire-cite-metadata-volume highwire-cite-metadata">10 </span><span  class="highwire-cite-metadata-issue highwire-cite-metadata">(1) </span><span  class="highwire-cite-metadata-pages highwire-cite-metadata">53-63; </span></div>
  
  
  
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<div id="hw-article-author-popups-top-node-13273--8564504029" style="display: none;"><div class="author-tooltip-0"><div class="author-tooltip-name">Eric J. Russell </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>1</span> Department of Diagnostic Radiology, Northwestern Memorial Hospital and Northwestern University Medical School, Olson Pavilion, 710 N. Fairbanks Ct., Chicago, IL 60611. Address reprint requests to E. J. Russell.</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=Eric%2BJ.%2BRussell%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=Russell%20EJ&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%3AEric%2BJ.%2BRussell%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-1"><div class="author-tooltip-name">Thomas F. Schaible </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>2</span> Berlex Laboratories, Inc., Cedar Knolls, NJ 07927.</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=Thomas%2BF.%2BSchaible%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=Schaible%20TF&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%3AThomas%2BF.%2BSchaible%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-2"><div class="author-tooltip-name">William Dillon </div><div class="author-tooltip-affiliation"><span class="author-tooltip-text"><div class='author-affiliation'><span class='nlm-sup'>3</span> Department of Radiology, University of California School of Medicine, San Francisco, CA 94143-0638.</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=William%2BDillon%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=Dillon%20W&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%3AWilliam%2BDillon%2B" rel="nofollow" class="" 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    <div class="highwire-markup"><div xmlns="http://www.w3.org/1999/xhtml" class="content-block-markup" xmlns:xhtml="http://www.w3.org/1999/xhtml"><div xmlns:xhtml="http://www.w3.org/1999/xhtml" class="contributors"><ol class="contributor-list" id="contrib-group-1"><li class="contributor" id="contrib-1"><span class="name">Eric J. Russell</span><a id="xref-aff-1-1" class="xref-aff" href="#aff-1">1</a>, </li><li class="contributor" id="contrib-2"><span class="name">Thomas F. Schaible</span><a id="xref-aff-2-1" class="xref-aff" href="#aff-2">2</a>, </li><li class="contributor" id="contrib-3"><span class="name">William Dillon</span><a id="xref-aff-3-1" class="xref-aff" href="#aff-3">3</a>, </li><li class="contributor" id="contrib-4"><span class="name">Burton Drayer</span><a id="xref-aff-4-1" class="xref-aff" href="#aff-4">4</a>, </li><li class="contributor" id="contrib-5"><span class="name">Joseph LiPuma</span><a id="xref-aff-5-1" class="xref-aff" href="#aff-5">5</a>, </li><li class="contributor" id="contrib-6"><span class="name">Anthony Mancuso</span><a id="xref-aff-6-1" class="xref-aff" href="#aff-6">6</a>, </li><li class="contributor" id="contrib-7"><span class="name">Kenneth Maravilla</span><a id="xref-aff-7-1" class="xref-aff" href="#aff-7">7</a> and </li><li class="last" id="contrib-8"><span class="name">Harold A. Goldstein</span><a id="xref-aff-2-2" class="xref-aff" href="#aff-2">2</a></li></ol><ol class="affiliation-list"><li class="aff"><a id="aff-1" name="aff-1"></a><address><sup>1</sup> Department of Diagnostic Radiology, Northwestern Memorial Hospital and Northwestern University Medical School, Olson Pavilion, 710 N. Fairbanks Ct., Chicago, IL 60611. Address reprint requests to E. J. Russell.</address></li><li class="aff"><a id="aff-2" name="aff-2"></a><address><sup>2</sup> Berlex Laboratories, Inc., Cedar Knolls, NJ 07927.</address></li><li class="aff"><a id="aff-3" name="aff-3"></a><address><sup>3</sup> Department of Radiology, University of California School of Medicine, San Francisco, CA 94143-0638.</address></li><li class="aff"><a id="aff-4" name="aff-4"></a><address><sup>4</sup> Barrow Neurological Institute, Phoenix, AZ 85013.</address></li><li class="aff"><a id="aff-5" name="aff-5"></a><address><sup>5</sup> Department of Radiology, University Hospitals, Cleveland, OH 44106.</address></li><li class="aff"><a id="aff-6" name="aff-6"></a><address><sup>6</sup> Department of Radiology, University of Florida College of Medicine, Gainesville, FL 32610.</address></li><li class="aff"><a id="aff-7" name="aff-7"></a><address><sup>7</sup> Department of Radiology, University of Washington School of Medicine, Seattle, WA 98195.</address></li></ol></div></div></div>  </div>

  
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