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Study to Assess Efficacy and Safety of Contrast Agents in MR Mammography

By MedImaging International staff writers
Posted on 14 Apr 2010
An international clinical phase III study has been started to develop the contrast agent Gadovist (gadobutrol) for use in magnetic resonance imaging (MRI) of the breast. The trial will evaluate the efficacy and safety of Gadovist in contrast-enhanced breast MR mammography (MRM).

Gadovist is already approved for the most frequently used contrast-enhanced MRI examinations including imaging of the central nervous system, the liver, kidney, and for imaging of blood vessels in adults and for the use in children aged two years and older.

"As a pioneer in contrast-media research, Bayer is continuously working to provide physicians with high-quality contrast media for use in various indications of contrast enhanced MRI,” said Thomas Balzer, head of global clinical development diagnostic imaging at Bayer Schering Pharma, AG (Berlin, Germany). "Due to its high T1-shortening--an important characteristic in the field of radiology--Gadovist offers a potentially excellent image quality in MRI and thus could be very valuable in MRM.”

The objective of this multicenter, open-label, nonrandomized phase III study with corresponding blinded image evaluations is to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of Gadobutrol 1.0 Molar (Gadovist) in patients with newly diagnosed breast cancer referred for contrast-enhanced breast MRI. The extent of malignant disease will be determined and compared between various imaging approaches, including unenhanced breast MRI, gadobutrol-enhanced MRI, and X-ray mammography. The active enrollment phase III will cover one year with the estimated completion date around beginning 2011.

With about 1.3 million new cases every year, breast cancer is the most common form of cancer among women today. Diagnostic imaging plays an important role in the detection and management of this devastating disease. MRI is considered the most sensitive method for detection of breast cancer and the best method to exclude additional cancer lesions. Therefore, it is used as an adjunct to X-ray mammography for, e.g., screening high-risk patients, preoperative tumor staging, tracking response to neo-adjuvant chemotherapy, and evaluating breast implants. The MRI procedure consists of unenhanced and contrast-enhanced MRI scans to differentiate into benign and malignant lesions using morphologic (shape and margin) and dynamic (contrast enhancement, signal intensity time curves) criteria. The performance of MRI strongly depends on the efficacy and safety of the applied contrast agent.

Gadovist is a highly efficient contrast agent, approved for the contrast-enhanced MRI of various parts of the body, including the brain, spinal cord, liver, kidney, and the blood-vessel system. With its 1.0 mol/L concentration of gadobutrol, a stable macrocyclic gadolinium compound, Gadovist contains twice as much gadolinium per unit of volume as other extracellular contrast media available on the market. Moreover, Gadovist has a high T1-relaxivity in plasma. Due to its combination of high concentration and high relaxivity, Gadovist exhibits the highest T1-shortening per mL of all gadolinium contrast media. This results in potentially excellent image quality and offers practical advantages in the case of smaller injection volumes. Gadovist received market authorization for the first time in 1998 and it is now approved in over 50 countries.

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition, and high-tech materials. Bayer HealthCare (Leverkusen, Germany), a subsidiary of Bayer AG, is one of the world's leading innovative companies in the healthcare and medical products industry. The company combines the global activities of the animal health, Bayer Schering Pharma, consumer care and medical care divisions. Bayer HealthCare's goal is to discover, manufacture, and market products that will improve human and animal health worldwide.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: diagnostic imaging, general Medicine, specialty medicine, and women's healthcare.

Related Links:
Bayer Schering Pharma
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88 (31.948089599609): SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294728929 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
89 (35.04753112793): 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 (56.028366088867): SELECT show_live FROM jos_com_show_setting LIMIT 1
91 (32.186508178711): SELECT show_live FROM jos_com_show_setting LIMIT 1
92 (58.889389038086): SELECT show_live FROM jos_com_show_setting LIMIT 1
93 (33.140182495117): SELECT show_live FROM jos_com_show_setting LIMIT 1
94 (41.007995605469): SELECT show_live FROM jos_com_show_setting LIMIT 1
95 (40.054321289062): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (35.04753112793): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (29.087066650391): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (26.941299438477): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (28.133392333984): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (66.041946411133): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
105 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
106 (68.902969360352): 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
107 (51.021575927734): 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
108 (80.82389831543): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
109 (54.836273193359): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
110 (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 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
111 (478.02925109863): 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
112 (504.97055053711): 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 (315.90461730957): 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 (66.995620727539): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
115 (44.107437133789): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
116 (104.18891906738): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
117 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
118 (46.014785766602): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
119 (36.954879760742): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
120 (47.922134399414): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
121 (51.975250244141): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
122 (238.89541625977): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
123 (!!!!! 37324.190139771): 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 (!!!!! 1539.945602417): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294728929 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294728929 AND type='deeppockets_item' AND published='1' LIMIT 1
125 (!!!!! 10781.049728394): ( 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 (159.97886657715): ( 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 (385.99967956543): 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 (40.054321289062): 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 (221.01402282715): 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 (34.093856811523): 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 (182.15179443359): 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 (32.901763916016): 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 (202.89421081543): 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 (36.954879760742): 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 (491.14227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
136 (375.03242492676): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
137 (234.12704467773): SELECT name FROM jos_deeppockets WHERE id=212
138 (36.001205444336): SELECT name FROM jos_deeppockets WHERE id=212
139 (564.8136138916): 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((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
140 (535.96496582031): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))212((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
141 (66.041946411133): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
142 (43.153762817383): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
143 (!!!!! 12645.00617981): TRUNCATE TABLE jos_trademed_module
144 (111.10305786133): 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
145 (78.201293945312): 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=294728929 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
146 (354.05158996582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
147 (92.983245849609): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
148 (102.04315185547): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
149 (114.91775512695): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
150 (!!!!! 1284.8377227783): 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 (53.167343139648): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
152 (41.961669921875): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
153 (41.007995605469): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=294728929 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=294728929 AND type='deeppockets_item' AND published='1' LIMIT 1
154 (29.087066650391): 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 (27.894973754883): 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 (32.901763916016): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
157 (122.0703125): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
158 (49.114227294922): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=294728929 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=294728929 AND published='1' LIMIT 1
159 (94.890594482422): select jos_twitters.link from jos_twitters where cat=10
160 (27.894973754883): select jos_facebook.link from jos_facebook where cat=10
161 (26.941299438477): select jos_google_plus.link from jos_google_plus where cat=10
162 (26.941299438477): select jos_linkedin.link from jos_linkedin where cat=10
163 (257.96890258789): update jos_bannersmanager_banner set impmade=impmade+1 where id in(14615,14202,14203)
164 (!!!!! 5333.9004516602): insert into jos_banners_delta values (14615,'2025-06-28 11:58:59','216.73.216.249','view'),(14202,'2025-06-28 11:58:59','216.73.216.249','view'),(14203,'2025-06-28 11:58:59','216.73.216.249','view')