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First US Injection of MR Contrast Agent Gadoterate Meglumine Performed

By MedImaging International staff writers
Posted on 21 Aug 2013
In July 2013, US radiologists performed the first injection of gadoterate meglumine (Dotarem), the only macrocyclic and ionic gadolinium-based contrast agent (GBCA) approved by the US Food and Drug Administration (FDA). The procedure was performed in a school-age child.

Dotarem is indicated for intravenous use (IV) with magnetic resonance imaging (MRI) in spine, brain (intracranial), and associated tissues in adult and pediatric patients (two years of age and older) to identify and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

“The availability of a macrocyclic and ionic gadolinium-based contrast agent that is FDA-approved for use in children ages 2–18 is very desirable,” said Dr. Daniel Podberesky, chief of thoracoabdominal imaging in the department of radiology, Cincinnati Children’s Hospital Medical Center (OH, USA),where the procedure was done.

Dotarem, developed by Guerbet (Villepinte, France), was approved by the FDA in March 2013, and was released for the US market in early July. Cincinnati Children’s was the first hospital to order the product in the United States. In 2012, Cincinnati Children’s performed 18,000 total MRI scans, with more than 6,600 performed as contrast-enhanced MRI scans.

“We are extremely pleased that Cincinnati Children’s Hospital Medical Center is the first hospital to use Dotarem to enhance an MRI procedure,” said Massimo Carrara, general manager, Guerbet US. “This reinforces the need for this product.”

Dotarem, which has been widely marketed outside the United States since 1989 and more than 37 million doses administered, is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmoL/kg) body weight (BW). Dotarem Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and prfilled syringes.

MRI has become the gold standard of central nervous system (CNS) imaging since its introduction over 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI scans performed in the United States in 2011, with about 60% of these examinations performed to image the CNS.

The Dotarem new drug application (NDA) included two phase III clinical studies. These studies evaluated the diagnostic efficacy and safety of Dotarem for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine, and associated tissues in adult and pediatric patients (two years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Both phase III studies assessed the better quality of the enhanced images over the unenhanced images for CNS lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the effectiveness of Dotarem at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy and safety of Dotarem-enhanced MRI.

Commercialized widely in over 70 countries in Europe, Asia, Africa, Middle East, and South America, more than 37 million doses of Dotarem have been administered. The approved indications for Dotarem may vary between countries. Dotarem is the leading contrast agent in Europe with 47% market share in 2012.

A pioneer in the field of contrast agents with more than 80 years of experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such, it has a complete offering of contrast products for X-ray and MRI and for interventional radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients.

To promote the discovery of new products and assure future growth, Guerbet allocates substantial resources to research and development every year (approximately 10% of sales). Guerbet also markets other contrast agents in the United States.

Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with noncontrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle, and internal organs.

Related Links:
Cincinnati Children’s Hospital Medical Center
Guerbet


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87 (71.048736572266): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
88 (39.815902709961): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
89 (32.901763916016): SELECT id,name,title FROM jos_deeppockets WHERE cat=10 AND TYPE='file_folder' AND published=1 AND id != 294743300 AND id != 294743301 AND id != 294743302 AND id != 294743303 AND id != 294743304 AND id != 294743305 AND id != 294743306 AND id != 294743307 AND id != 294743308 AND id != 294743309 AND id != 294743310 AND metakey != 'aacc' ORDER BY `ordering`
90 (53.882598876953): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (30.994415283203): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (28.848648071289): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (34.093856811523): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (29.087066650391): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (30.040740966797): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (27.894973754883): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (62.942504882812): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
105 (44.107437133789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
106 (47.922134399414): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (46.968460083008): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (81.062316894531): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
109 (44.107437133789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
110 (65.088272094727): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (555.99212646484): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (742.91229248047): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
113 (557.89947509766): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
114 (193.83430480957): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
115 (85.115432739258): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
116 (93.936920166016): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
117 (67.949295043945): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
118 (67.949295043945): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
119 (56.028366088867): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
120 (69.141387939453): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
121 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
122 (422.95455932617): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 27565.956115723): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
124 (496.14906311035): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294747835 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294747835 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 15845.060348511): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
126 (257.96890258789): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
127 (127.07710266113): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
128 (120.87821960449): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
129 (112.05673217773): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
130 (153.77998352051): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
131 (!!!!! 3963.9472961426): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
132 (103.95050048828): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
133 (77.962875366211): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
134 (44.107437133789): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
135 (!!!!! 1264.0953063965): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (545.97854614258): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (61.03515625): SELECT name FROM jos_deeppockets WHERE id=212
138 (43.869018554688): SELECT name FROM jos_deeppockets WHERE id=212
139 (!!!!! 1280.0693511963): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (742.19703674316): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (!!!!! 4199.9816894531): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
142 (148.05793762207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
143 (!!!!! 16072.034835815): TRUNCATE TABLE jos_trademed_module
144 (87.02278137207): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (55.074691772461): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=294747835 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (!!!!! 1473.9036560059): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (113.01040649414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (105.14259338379): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
149 (67.949295043945): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
150 (!!!!! 1600.0270843506): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
151 (99.18212890625): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
152 (61.03515625): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
153 (43.869018554688): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294747835 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294747835 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (41.007995605469): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
155 (36.001205444336): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=212 or channel_id is null)
156 (39.100646972656): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (159.97886657715): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
158 (65.803527832031): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294747835 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294747835 AND published='1' LIMIT 1
159 (61.988830566406): select jos_twitters.link from jos_twitters where cat=10
160 (43.153762817383): select jos_facebook.link from jos_facebook where cat=10
161 (39.100646972656): select jos_google_plus.link from jos_google_plus where cat=10
162 (36.954879760742): select jos_linkedin.link from jos_linkedin where cat=10
163 (364.06517028809): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 1074.0756988525): insert into jos_banners_delta values (14615,'2025-06-25 08:42:06','216.73.216.120','view'),(14202,'2025-06-25 08:42:06','216.73.216.120','view'),(14203,'2025-06-25 08:42:06','216.73.216.120','view')