Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The purpose of this study was to evaluate the safety and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in hepatic MRI of patients with suspected liver pathology. A Phase III, multicenter, randomized, double-blind, parallel group study was performed in adults with suspected liver pathology. All patients underwent contrast-enhanced computed tomography within 3 weeks prior to magnetic resonance scanning. Ninety-nine patients received OptiMARK, and 94 patients received Magnevist at a dose of 0.1 mmol/kg. Precontrast T1- and T2-weighted spin-echo imaging and T1-weighted gradient-echo imaging were performed, followed by T1-weighted gradient-echo imaging at 15-20 seconds, 1 minute, and 5 minutes after intravenous contrast injection. Three primary efficacy endpoints (confidence in lesion diagnosis, level of conspicuity, and lesion border delineation) were evaluated on the precontrast image set and compared with the pre plus postcontrast image set. Vital signs, physical examination, electrocardiograms (ECGs), and laboratory parameters (chemistry, hematology, and urinalysis) were measured at various time points. Adverse events were recorded. The study design and statistical analyses were chosen to demonstrate presumed equivalence of OptiMARK and Magnevist. There were no statistically significant differences in efficacy between OptiMARK and Magnevist as assessed by either blinded readers or the on-site principal investigators. No serious or unexpected adverse events were noted. Of the 193 patients receiving contrast media, 82 experienced a total of 154 adverse events. Thirty-three (21.4%) of these 154 adverse events were felt by the on-site investigators to be probably related to either study agent: 15 events in 9 patients in the OptiMARK group, and 18 events in 13 patients in the Magnevist group. Headache was the most common adverse event, occurring in 10.1% of the OptiMARK patients and 12.8% of the Magnevist patients. No clinically relevant trends were observed in any laboratory parameter or ECG findings in either treatment group. The results demonstrate the safety, efficacy, and equivalence of OptiMARK and Magnevist at a dose of 0.1 mmol/kg in hepatic magnetic resonance imaging of patients with suspected liver pathology.
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PMID:A multicenter, randomized, double-blind study to evaluate the safety, tolerability, and efficacy of OptiMARK (gadoversetamide injection) compared with Magnevist (gadopentetate dimeglumine) in patients with liver pathology: results of a Phase III clinical trial. 1007 20

This study was designed to assess the feasibility of intrathecal gadolinium-enhanced magnetic resonance cisternography (MRC) for the evaluation of the presence or absence of communication of cranial arachnoid cysts with the cerebrospinal fluid (CSF) pathways of the central nervous system (CNS). This prospective study included 20 patients (12 males and 8 females) with a mean age of 37 years, who had, as a group, 22 intracranial arachnoid cysts identified on prior CT and/or MR examinations. Routine pre-contrast cranial MR imaging was followed by the intrathecal administration of 0.5 cc gadopentetate dimeglumine (GD) (Magnevist, Schering, Germany). Immediate and delayed (24 h) MR cisternography was then carried out. Eleven of 22 arachnoid cysts showed immediate CSF communication by the demonstration GD-contrast enhancement of the cyst fluid on the immediate post-injection scan. Contrast enhancement of the cyst was observed only on delayed MRC in six patients. MR imaging in five patients demonstrated no contrast enhancement of the arachnoid cysts on either immediate or delayed imaging. Six patients had mild transient post-procedure headache that was relieved by oral analgesics within 24 h. No serious immediate or chronic adverse effects or complications relating to the intrathecal contrast administration were observed. This study showed the relative safety, feasibility and reliability of low-dose intrathecal GD MR imaging in the demonstration of the communication or non-communication of intracranial arachnoid cysts with the CSF pathways of the CNS. In the future, this may have bearing on the selection for surgery of patients with intracranial arachnoid cysts presenting with clinical signs and symptoms potentially related to the location and mass effect of the cyst.
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PMID:Intrathecal gadolinium (gadopentetate dimeglumine)-enhanced MR cisternography used to determine potential communication between the cerebrospinal fluid pathways and intracranial arachnoid cysts. 1528 56