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Generated: February 22, 2019

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CLINICAL TRIALS PROFILE FOR GADOBENATE DIMEGLUMINE

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Clinical Trials for Gadobenate Dimeglumine

Trial ID Title Status Sponsor Phase Summary
NCT00323310 Safety and Efficacy of MultiHance in Pediatric Patients Terminated Bracco Diagnostics, Inc Phase 3 The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
NCT01165892 Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar) Completed Lantheus Medical Imaging N/A The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01165892 Pulmonary MR Angiography and Lower Extremity MR Venous Imaging Using Gadofosveset (Ablavar) Completed Washington University School of Medicine N/A The use of the contrast agent, Ablavar, will help with the diagnosis of pulmonary embolism in magnetic resonance imaging (MRI).
NCT01260636 Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries Completed Bracco Diagnostics, Inc Phase 3 To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
NCT02226666 Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration Active, not recruiting University of Michigan N/A The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).
NCT02291822 Retrospective Study of MRI in Pediatric Patients Completed Bracco Diagnostics, Inc N/A Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.
NCT02487277 PEGPH20, Gemicitabine and Nab-Paclitaxel for Pancreatic Ductal Adenocarcinoma Recruiting Andrew Ko Phase 2 We will be conducting a Phase II study investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel in patients with borderline resectable PDAC at the Helen Diller Family Comprehensive Cancer Center at UCSF. There are multiple definitions of borderline resectable PDAC including the MD Anderson definition and the criteria developed during the Consensus Conference sponsored by the American Hepato-Pancreato-Biliary Association, Society of Surgical Oncology, and Society for Surgery of the Alimentary Tract. Borderline resectable PDAC cases will be identified per the definition developed in the currently running inter-group pilot trial for borderline resectable pancreatic cancer (NCT01821612). Per this trial, borderline resectable PDAC is defined as "presence of any one or more of the following on CT: - An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring ≥ 180° of the circumference of the vessel wall - Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction - Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction. - An interface between the tumor, and SMA measuring < 180º of the circumference of the vessel wall. This trial will be conducted in two parts. In Part I, pre-treatment EUS-guided core biopsies of the pancreatic tumor, CA 19-9 levels and functional MRIs including DCE-MRI and DWI-MRI will be obtained for the first fifteen patients enrolled. After a 1-week run-in period with PEGPH20 on days 1 and 4, patients will have repeat EUS-guided core biopsies, functional MRI, CA 19-9 level and baseline CT chest, abdomen and pelvis. Subsequently, patients will be started on treatment with PEGPH20, gemcitabine and nab-paclitaxel given weekly for 3 weeks, every 28 days. To evaluate the disease response to treatment, CA 19-9 levels will be checked monthly and restaging CT chest, abdomen and pelvis will be obtained every 8 weeks. If there is disease progression at any point in the study, patients will be taken off of study and alternative treatments will be offered. At the completion of 4 cycles of therapy, restaging CT scans will be obtained to determine resectability. If the patients are found to have resectable disease, an additional functional MRI will be obtained to evaluate the PDAC stroma. If the patients are able to have successful surgeries, tissue analyses will be performed on the resected pancreatic tumor. These patients will then proceed to get 2 cycles of adjuvant chemotherapy with gemcitabine and nab-paclitaxel. If the patients are deemed to be surgical candidates but are found to have unresectable disease in the operating room, an intraoperative core biopsy of the pancreatic tumor will be obtained for tissue analyses. At the time of initiation of therapy with PEGPH20, patients will be started on prophylactic dose of enoxaparin 1 mg/kg subcutaneous daily. This will be continued throughout the study participation. In Part II, an additional 21 patients will be enrolled, and will begin neoadjuvant therapy with PEGPH20, gemcitabine and nab-paclitaxel without the 1 week run-in of PEGPH20-only or the pre- and post-run-in EUS-guided biopsies.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gadobenate Dimeglumine

Condition Name

Condition Name for Gadobenate Dimeglumine
Intervention Trials
Adult Brain Stem Glioma 1
Carotid, Aortic, Renal or Peripheral Artery Disease 1
Adult Glioblastoma 1
Liver Tumor 1
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Condition MeSH

Condition MeSH for Gadobenate Dimeglumine
Intervention Trials
Nervous System Diseases 2
Central Nervous System Diseases 2
Neuroectodermal Tumors, Primitive 1
Brain Neoplasms 1
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Clinical Trial Locations for Gadobenate Dimeglumine

Trials by Country

Trials by Country for Gadobenate Dimeglumine
Location Trials
United States 6
Italy 1
Poland 1
China 1
Hungary 1
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Trials by US State

Trials by US State for Gadobenate Dimeglumine
Location Trials
California 2
Michigan 2
Wisconsin 1
New Jersey 1
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Clinical Trial Progress for Gadobenate Dimeglumine

Clinical Trial Phase

Clinical Trial Phase for Gadobenate Dimeglumine
Clinical Trial Phase Trials
Phase 3 2
Phase 2 3
N/A 4
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Clinical Trial Status

Clinical Trial Status for Gadobenate Dimeglumine
Clinical Trial Phase Trials
Completed 3
Recruiting 2
Terminated 2
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Clinical Trial Sponsors for Gadobenate Dimeglumine

Sponsor Name

Sponsor Name for Gadobenate Dimeglumine
Sponsor Trials
Bracco Diagnostics, Inc 3
National Cancer Institute (NCI) 2
University of Michigan 1
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Sponsor Type

Sponsor Type for Gadobenate Dimeglumine
Sponsor Trials
Other 5
Industry 5
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
Covington
Daiichi Sankyo
Argus Health
US Army
Julphar
US Department of Justice
UBS

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