2000
Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety)
Federle M, Chezmar J, Rubin D, Weinreb J, Freeny P, Semelka R, Brown J, Borrello J, Lee J, Mattrey R, Dachman A, Saini S, Harmon B, Fenstermacher M, Pelsang R, Harms S, Mitchell D, Halford H, Anderson M, Johnson C, Francis I, Bova J, Kenney P, Klippenstein D, Foster G, Turner D, Stillman A, Nelson R, Young S, Patt R, Rifkin M, Seltzer S, Gay S, Robison R, Sherwin P, Ballerini R. Safety and Efficacy of Mangafodipir Trisodium (MnDPDP) Injection for Hepatic MRI in Adults: Results of the U.S. Multicenter Phase III Clinical Trials (Safety). Journal Of Magnetic Resonance Imaging 2000, 12: 186-197. PMID: 10931579, DOI: 10.1002/1522-2586(200007)12:1<186::aid-jmri21>3.0.co;2-2.Peer-Reviewed Original ResearchMeSH KeywordsAbdominal PainAdultAgedAged, 80 and overCardiovascular DiseasesContrast MediaDiagnosis, DifferentialEdetic AcidFemaleHumansImage EnhancementInjections, IntravenousLiver CirrhosisLiver NeoplasmsMagnetic Resonance ImagingMaleMiddle AgedPainPregnancyPyridoxal PhosphateRisk AssessmentSensitivity and SpecificityVomitingConceptsMagnetic resonance imagingMangafodipir trisodium injectionAdverse eventsMulticenter phase III clinical trialContrast-enhanced computed tomography examinationPhase III clinical trialsUnenhanced magnetic resonance imagingInjection of MnDPDPInjection-associated discomfortSerious adverse eventsShort-term safetyHepatic magnetic resonance imagingComputed tomography examinationSignificant short-term riskShort-term riskFocal liver lesionsClinical trialsTomography examinationLaboratory valuesLiver lesionsResonance imagingVital signsPatientsMnDPDPInjection
1999
A multisite phase III study of the safety and efficacy of a new manganese chloride‐based gastrointestinal contrast agent for MRI of the abdomen and pelvis
Small W, DeSimone‐Macchi D, Parker J, Sukerkar A, Hahn P, Rubin D, Zelch J, Kuhlman J, Outwater E, Weinreb J, Brown J, de Lange E, Woodward P, Arildsen R, Foster G, Runge V, Aisen A, Muroff L, Thoeni R, Parisky Y, Tanenbaum L, Totterman S, Herfkens R, Knudsen J, Laster R, Duerinckx A, Stillman A, Spritzer C, Saini S, Rofsky N, Bernardino M. A multisite phase III study of the safety and efficacy of a new manganese chloride‐based gastrointestinal contrast agent for MRI of the abdomen and pelvis. Journal Of Magnetic Resonance Imaging 1999, 10: 15-24. PMID: 10398973, DOI: 10.1002/(sici)1522-2586(199907)10:1<15::aid-jmri3>3.0.co;2-x.Peer-Reviewed Original ResearchConceptsGastrointestinal contrast agentAdverse eventsSite investigatorsGastrointestinal tract side effectsPatient diagnosisBlinded readersMore adverse eventsPhase III studyInflammatory bowel diseaseGroup of patientsPeptic ulcer diseaseML of placeboT2-weighted MRI scansMultisite clinical trialContrast agentsOral contrast agentAdditional diagnostic informationPlacebo patientsOral agentsIII studyBowel diseaseUlcer diseaseGastrointestinal pathologyLaboratory changesPhysical examination
1993
Use of the Magnetic Resonance Contrast Agent Gadodiamide in the Central Nervous System Results of a Multicenter Trial
SZE G, BRANT-ZAWADZKI M, McNAMARA M, HAUGHTON V, KUMAR A, MARAVILLA K, AISEN A, DREISBACH J, BRADLEY W, WEINREB J, DRAYER B, TSURUDA J, HESSELINK J, JOHNSON C, ZIMMERMAN R, WEINGAST G. Use of the Magnetic Resonance Contrast Agent Gadodiamide in the Central Nervous System Results of a Multicenter Trial. Investigative Radiology 1993, 28: s49-s55. PMID: 8486504, DOI: 10.1097/00004424-199303001-00006.Peer-Reviewed Original ResearchConceptsMagnetic resonance imagingPhase II/III clinical trialsVital signsCentral nervous system resultsSignificant adverse eventsNervous system resultsNonionic contrast agentsVisualization of lesionsPreinjection imagesAdverse eventsNeurologic statusMulticenter trialClinical statusMulticenter studyClinical trialsPatient's vital signsMRI scansGadodiamide injectionPatientsResonance imagingSafety parametersContrast enhancementInjectionTrialsSpine
1992
Manganese (II) N,N'-dipyridoxylethylenediamine-N,N'-diacetate 5,5'-bis(phosphate): clinical experience with a new contrast agent.
Rofsky N, Weinreb J. Manganese (II) N,N'-dipyridoxylethylenediamine-N,N'-diacetate 5,5'-bis(phosphate): clinical experience with a new contrast agent. Magnetic Resonance Quarterly 1992, 8: 156-68. PMID: 1390058.Peer-Reviewed Original ResearchConceptsMagnetic resonance imagingMn-DPDPN'-dipyridoxylethylenediamineClinical experienceNon-enhanced T1Significant adverse eventsEnhanced magnetic resonance imagingManganese NT2-weighted imagesAdverse eventsHepatocellular originClinical trialsContrast agentsHepatobiliary agentsResonance imagingLiver imagingFavorable resultsLesion detectionNew contrast agentsIssues of safetyImaging techniquesAgentsImagingOptimal methodNumerous strategies
1991
Multicenter study of gadodiamide injection as a contrast agent in MR imaging of the brain and spine.
Sze G, Brant-Zawadzki M, Haughton V, Maravilla K, McNamara M, Kumar A, Aisen A, Dreisbach J, Bradley W, Weinreb J. Multicenter study of gadodiamide injection as a contrast agent in MR imaging of the brain and spine. Radiology 1991, 181: 693-9. PMID: 1947084, DOI: 10.1148/radiology.181.3.1947084.Peer-Reviewed Original ResearchConceptsCentral nervous systemGadodiamide injectionNervous systemMR imagingSerious adverse eventsContrast material enhancementVisualization of lesionsMagnetic resonance imagingNeurologic statusAdverse eventsMulticenter studyLaboratory valuesPatientsResonance imagingVital signsLesionsUnenhanced imagesSpinePhase IIInjectionMaterial enhancementContrast agentsMR imagesGadolinium chelate complexesImaging