Abstract:
RATIONALE AND OBJECTIVES:To present the results of two studies conducted to evaluate the pharmacokinetics and safety of iomeprol in healthy volunteers and in patients with various degrees of renal impairment. METHODS:In these two open-label, single-dose, phase I studies, a 50-mL dose of iomeprol 400 was administered intravenously to a total of 30 subjects of either sex. In study 1, six healthy volunteers with normal renal function, six patients with mild renal failure, six patients with moderate renal failure, and four patients with severe renal failure were enrolled. In study 2, eight patients with end-stage renal disease requiring hemodialysis were enrolled. Safety was determined by predose and postdose (up to 10 days) measurement of vital signs, hematology, blood chemistry, urinalysis, electrocardiogram, physical examinations, and the incidence of adverse events. Pharmacokinetics was determined by measuring iomeprol levels in plasma, urine, feces, and dialysate samples, by using a validated high-performance liquid chromatography assay, up to 7 days after administration. RESULTS:The plasma concentration of iomeprol declined biexponentially in both healthy subjects and patients. As expected, mean body and renal clearances decreased progressively with increasing renal impairment, with a significant correlation with the glomerular filtration rate. The elimination half-life increased progressively with increasing renal impairment. The extraction efficiency of dialyser was estimated as approximately 40%, and dialysis clearance of iomeprol was approximately 1.26 mL. min-1. kg-1 (80.6 mL/min), slightly less than the body clearance previously observed in healthy subjects. It appears that dialysis is almost as efficient as renal function in healthy subjects in the removal of iomeprol. After a single dialysis session, approximately 58% of the dose was recovered in dialysate. Mild to moderate adverse events were reported by 17 of 30 subjects; none was clinically meaningful. One serious adverse event, unrelated to iomeprol, was reported. No clinically meaningful findings were noted for other safety parameters. CONCLUSIONS:Iomeprol was almost completely eliminated both in patients with renal impairment and in patients receiving dialysis. No dose adjustment appears to be necessary either in patients with renal impairment or with end-stage renal disease requiring hemodialysis. In this risk population, iomeprol 400 was safe and well tolerated.
journal_name
Invest Radioljournal_title
Investigative radiologyauthors
Lorusso V,Taroni P,Alvino S,Spinazzi Adoi
10.1097/00004424-200106000-00002keywords:
subject
Has Abstractpub_date
2001-06-01 00:00:00pages
309-16issue
6eissn
0020-9996issn
1536-0210journal_volume
36pub_type
临床试验,杂志文章abstract:RATIONALE AND OBJECTIVES:Diabetic patients frequently suffer contrast media-induced nephropathy. Hyperglycemia in diabetes mellitus causes gradual deterioration of glomerular mesangial cells (MCs) in the kidney. In this study, the authors investigated the response of rat MCs cultured in high-glucose medium to diatrizoa...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-200107000-00001
更新日期:2001-07-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:The authors compare the magnetic resonance (MR) phase contrast flow velocity measurements in varying concentric stenoses with invasive measurements obtained with a Doppler guidewire. METHODS:Flow velocity measurements were obtained using a calibrated 0.018 inch 12 MHz Doppler guidewire and a 1...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-199808000-00001
更新日期:1998-08-01 00:00:00
abstract:PURPOSE:To evaluate the diagnostic performance of 1.0-M gadobutrol-enhanced, 3-dimensional (3D), dynamic MR images with 3D-MR cholangiography (MRC) in the preoperative evaluation of bile duct cancer staging and resectability. MATERIALS AND METHODS:Our institutional review board approved this retrospective study. Sixty...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0b013e3181d2eeb1
更新日期:2010-04-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to conduct a radiopathologic evaluation of right-angled traction bronchiectasis to differentiate idiopathic pulmonary fibrosis (IPF) without honeycombing from idiopathic nonspecific interstitial pneumonia (NSIP). MATERIALS AND METHODS:The derivation cohort included 78 consecutive p...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0000000000000651
更新日期:2020-06-01 00:00:00
abstract::Radiolabeled ioversol was injected intravenously into two male and two female beagle dogs (6.7 to 10.4 kg) at two dose levels each (0.2 and 1.0 g I/kg). Blood levels of radioactivity were monitored at 2, 5, 10, 20, 40, 60, 90, and 120 minutes and at one and two days. Urine and feces were collected in metabolism cages ...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198906001-00005
更新日期:1989-06-01 00:00:00
abstract::Effectiveness of terbutaline, a potent uterine muscle relaxant, for differentiation of temporary and anatomic interstitial fallopian tube obstruction (IFTO) at hysterosalpingography (HSG) was explored. In 43 IFTO evaluated, HSG after terbutaline showed patency in only one of 16 tubes in which IFTO was caused by spasm ...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198803000-00010
更新日期:1988-03-01 00:00:00
abstract::Ionic (diatrizoate, ioxaglate) and nonionic (iohexol, iosimide, iopromide, and iotrolan) contrast media (CM) were evaluated for their cytogenetic effects in lymphocytes. Heparinized blood was mixed with culture medium RPMI-1640 supplemented with phytohemagglutinin, fetal calf serum, and antibiotics. Plastic tubes cont...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198611000-00006
更新日期:1986-11-01 00:00:00
abstract:OBJECTIVES:The goal of this study was to demonstrate feasibility of measuring extracellular pH in cartilage and meniscus using acidoCEST technique with a 3-dimensional ultrashort echo time readout (acidoCEST-UTE) magnetic resonance imaging (MRI). MATERIALS AND METHODS:Magnetization transfer ratio asymmetry, radiofrequ...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0000000000000576
更新日期:2019-09-01 00:00:00
abstract::The cerebrovascular toxicity of three water-soluble contrast agents with a low hypertonicity (metrizamide, ioxaglate, iopamidol) was tested. Blood-brain barrier damage after carotid injection was assessed using 32P autoradiography and fluorescent microscopy after Evans blue staining. The damage to carotid endothelium ...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198011001-00058
更新日期:1980-11-01 00:00:00
abstract::The purpose of our investigation was to determine whether iopanoyl glucuronide, the major metabolite of iopanoic acid (Telepaque), undergoes hydrolysis by bacterial beta-glucuronidase in dogs. The conjugated compound was identified and quantitated by elemental analysis, fluorescent excitation analysis, thin-layer chro...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-197805000-00011
更新日期:1978-05-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:Tools for monitoring modern target-specific antiangiogenic and antivascular therapies are highly desirable because treatment strategies are time consuming, expensive, and yet sometimes ineffective. Therefore, the aim of this experimental study was to evaluate the predictive value of steady-stat...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0b013e3180d5cbd9
更新日期:2007-12-01 00:00:00
abstract::A diatrizoate compound (Renografin-76) and low osmolality Hexabrix were compared in a double-blind study of 50 adults undergoing arteriographic examination. Subjective and objective assessment of pain reaction for each contrast injection rated lower overall for Hexabrix. Discomfort associated with Renografin was great...
journal_title:Investigative radiology
pub_type: 临床试验,杂志文章
doi:10.1097/00004424-198411001-00012
更新日期:1984-11-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:The authors conduct technical feasibility and performance studies on a new 0.009-inch nitinol microguidewire for potential neuroendovascular applications. METHODS:In vivo microcatheterizations of brachiocephalic arteries were performed in four pigs using the 0.009-inch nitinol microguidewire w...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-199704000-00008
更新日期:1997-04-01 00:00:00
abstract:OBJECTIVE:To investigate the efficacy of true fast imaging with steady state precession (true-FISP) compared with T2-weighted fast spin echo (T2W-FSE) in monitoring changes in cyst volume and renal expansion in an ischemia reperfusion (IR) injured PKD1 knockout (IKO) mouse model. MATERIALS AND METHODS:The animal study...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0b013e3181be3501
更新日期:2010-01-01 00:00:00
abstract::Simultaneous inflation of two balloons may be necessary for balloon dilation valvuloplasty in patients with a large annulus. We examined the cardiovascular effects of dilating the pulmonary annulus with two balloons in 18 normal dogs using pulsed Doppler ultrasound and gross and microscopic examination. When the ratio...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198808000-00005
更新日期:1988-08-01 00:00:00
abstract::The cytogenetic interactions of ionic (diatrizoate, ioxaglate) and nonionic (iohexol) contrast media (CM) with antineoplastic drugs cyclophosphamide (CPA) and carmustine (CARM) were evaluated in a rat bone marrow cell model. Male Wistar rats were anesthetized with a 6% chloral hydrate solution and divided into five gr...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198805000-00011
更新日期:1988-05-01 00:00:00
abstract:OBJECTIVES:Imaging of the kidney using blood oxygen level dependent MR presents a major opportunity to examine differences in tissue oxygenation within the cortex and medulla applicable to human disease. We sought to define the differences between regions within kidneys and to optimize selection of regions of interest ...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0b013e3181b4c1e8
更新日期:2009-09-01 00:00:00
abstract:OBJECTIVES:To test the feasibility of a single MR-based examination allowing for the comprehensive assessment of renal anatomy, function, and vascular status in candidates for kidney transplantation. MATERIALS AND METHODS:Twelve healthy potential kidney donors (mean age: 47 +/- 14 [standard deviation] years, 3 men and...
journal_title:Investigative radiology
pub_type: 临床试验,杂志文章
doi:10.1097/RLI.0b013e3181b35a70
更新日期:2009-11-01 00:00:00
abstract:OBJECTIVES:The objective of this study was to evaluate the correlation between dynamic gadoxetic acid-enhanced magnetic resonance imaging parameters and specific uptake values (SUVs) derived from ¹⁸fluorodeoxyglucose (¹⁸F-FDG) and ⁶⁸Ga-DOTA-Tyr(3)-octreotate (⁶⁸Ga-DOTATATE) positron emission tomography/computed tomogra...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0b013e3182a4eb4a
更新日期:2014-01-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:To evaluate different vein graft-coated stent systems in the endovascular treatment of experimental arteriovenous fistulae (AVF) in a canine model. METHODS:Bilateral carotid-to-external jugular vein AVF were created. Two balloon-expandable tantalum stents (Strecker stent), two self-expanding n...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-199901000-00004
更新日期:1999-01-01 00:00:00
abstract::The authors reexamined a suspected difference in the effects of clinical information upon detection of nodules vs. more diverse lesions by directly incorporating classification specificity into detection ROC analysis. Categorical prompts, correct for specific abnormalities, led to detection superior to unprompted read...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-198801000-00011
更新日期:1988-01-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:To determine whether vascular endothelial growth factor (VEGF) is a histopathological factor influencing contrast enhancement of hepatocellular carcinoma (HCC) on computed tomography (CT). METHODS:Twenty-two nodular HCCs underwent multiphase helical CT and surgery. Tumor size, histological gra...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-200108000-00008
更新日期:2001-08-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to perform phantom measurements to prove the feasibility of single-source dual-energy computed tomography (DECT) of the extremities using a volume scan mode. In addition, we, for the first time, wanted to determine which concentrations of monosodium urate (MSU) in gout and calcium p...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0000000000000099
更新日期:2015-04-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to explore the impact of dynamic contrast-enhanced (DCE) computer tomography (CT) as a biomarker in metastatic renal cell carcinoma (mRCC). MATERIALS AND METHODS:Twelve patients with favorable or intermediate Memorial Sloan Kettering Cancer Center risk group and clear cell mRCC par...
journal_title:Investigative radiology
pub_type: 杂志文章,随机对照试验
doi:10.1097/RLI.0000000000000058
更新日期:2014-09-01 00:00:00
abstract:OBJECTIVES:The aim of this study was to evaluate the effect of structured reports (SRs) in comparison to nonstructured, free-text (FT) rectal magnetic resonance imaging (MRI) reports in patients with histologically proven rectal cancer and potential effects of both types of reporting on referring surgeons' satisfaction...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0000000000000336
更新日期:2017-04-01 00:00:00
abstract::Trypan blue and 197HgCl2 were used as markers of the increased leakage through the blood-brain barrier which developed after selective injection of different contrast media formulations into the internal carotid arteries of rabbits. Interest was focused on a new, experimental, nonionic medium (C-29) and possible effec...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-197907000-00007
更新日期:1979-07-01 00:00:00
abstract::Analysis of 46 sacroiliac joints removed in toto at random during routine autopsies was undertaken to define the pathologic and radiographic alterations of this joint in middle-aged and elderly patients. Each joint was sectioned, photographed and radiographed and large microscopic slides were prepared. Sacroiliac oste...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-197511000-00008
更新日期:1975-11-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:The authors used magnetic resonance imaging (MRI) techniques to examine the effect of meningeal trauma produced by cisterna magna puncture on the integrity of the blood-cerebrospinal fluid barrier (BCB) in a rat model. METHODS:Intravenous gadolinium-DTPA (Gd-DTPA), a relaxation rate modifier w...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/00004424-199204000-00008
更新日期:1992-04-01 00:00:00
abstract:OBJECTIVE:This study aims for targeted biopsy validation of magnetic resonance fingerprinting (MRF) and diffusion mapping for characterizing peripheral zone (PZ) prostate cancer and noncancers. MATERIALS AND METHODS:One hundred four PZ lesions in 85 patients who underwent magnetic resonance imaging were retrospectivel...
journal_title:Investigative radiology
pub_type: 杂志文章
doi:10.1097/RLI.0000000000000569
更新日期:2019-08-01 00:00:00
abstract:RATIONALE AND OBJECTIVES:This study was devised to develop a method of measuring the acute effects of radiocontrast media on renal function and assessing the relationship of the dose of radiocontrast media infused with the incidence of radiocontrast-induced renal failure. In addition, the drug adenosine phosphate-magne...
journal_title:Investigative radiology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1097/00004424-199406000-00004
更新日期:1994-06-01 00:00:00