GADOBUTROL ( DrugBank: Gadobutrol )


3 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎3
22もやもや病1
46悪性関節リウマチ1

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
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PhaseCountries
1NCT02967380
(ClinicalTrials.gov)
December 14, 201113/9/2015Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine Before DCE-MRI in Diagnosing Patients With Multiple Sclerosis, Grade II-IV Glioma, or Brain MetastasesDynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial LesionsAdult Anaplastic (Malignant) Meningioma;Adult Anaplastic Astrocytoma;Adult Anaplastic Ependymoma;Adult Anaplastic Oligodendroglioma;Adult Brain Stem Glioma;Adult Choroid Plexus Neoplasm;Adult Diffuse Astrocytoma;Adult Ependymoblastoma;Adult Ependymoma;Adult Giant Cell Glioblastoma;Adult Glioblastoma;Adult Gliosarcoma;Adult Grade II Meningioma;Adult Medulloblastoma;Adult Mixed Glioma;Adult Oligodendroglioma;Adult Papillary Meningioma;Adult Pineal Gland Astrocytoma;Adult Pineoblastoma;Adult Primary Melanocytic Lesion of Meninges;Adult Supratentorial Primitive Neuroectodermal Tumor;Malignant Adult Intracranial Hemangiopericytoma;Metastatic Malignant Neoplasm in the Brain;Multiple Sclerosis;Recurrent Adult Brain NeoplasmProcedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging;Drug: Gadobenate Dimeglumine;Drug: Gadobutrol;Radiation: Gadopentetate DimeglumineUniversity of Southern CaliforniaNational Cancer Institute (NCI)Terminated18 YearsN/AAll14N/AUnited States
2EUCTR2009-014857-34-DE
(EUCTR)
01/02/201021/12/2009Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MSIntra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS Patients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria
MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Gadovist 1.0 mmol/ml Injektionslösung
Product Code: V08CA09
INN or Proposed INN: GADOBUTROL
Other descriptive name: GADOBUTROL
Trade Name: Dotarem 0,5mmol/ml,
Product Code: V08CA02
INN or Proposed INN: gadoteric acid
Universitätsklinikum ErlangenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Germany
3EUCTR2009-016140-39-ES
(EUCTR)
19/01/201028/10/2009MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple.MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist®Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado
INN or Proposed INN: GADOBUTROL
Other descriptive name: GADOBUTROL
Institut Diagnostic per la ImatgeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain

22. もやもや病


臨床試験数 : 14 薬物数 : 21 - (DrugBank : 14) / 標的遺伝子数 : 28 - 標的パスウェイ数 : 44
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031180017
01/08/201807/09/2018Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular diseaseStudies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease - SMS DSC-MRI study for the occulusive cerebrobascular disease carotid artery stenosis, moyamoya diseaseIntravenous administration of gadobutrol (Gadovist, Bayer Schering Pharma, Berlin, Germany) is administered in the supine position, and high speed DSC-MRI scan by using SMS acquisition (temporal resolution of 0.5s) is carried out at the same time as injection of the contrast agent with an acquisition time of 70sec. The quantitative and qualitative comparison between reference data set (0.5s) and additional data sets with temporal resolution of 1.0s, 1.5s, and 2.0s generated from the reference data set, is performed.Aoki ShigekiBayer Yakuhin, Ltd;Bayer Yakuhin, LtdComplete>= 20age oldNot applicableBoth50N/AJapan

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02350426
(ClinicalTrials.gov)
August 12, 201515/12/2014A Study to Assess Inflammation in Rheumatoid Arthritis Using Molecular Imaging TechniquesAn Adaptive Design Open Label Pilot Study in Rheumatoid Arthritis Patients to Assess Inflammation Using Molecular Imaging TechniquesArthritis, RheumatoidOther: Gadobutrol;Other: 18F-FDG;Other: 18F-GE-180GlaxoSmithKlineCambridge University Hospitals NHS Foundation TrustTerminated30 Years85 YearsAll10Phase 1United Kingdom