[Show abstract][Hide abstract] ABSTRACT: The objective of the PREDICT (patients with renal impairment and diabetes undergoing computed tomography) study was to compare the incidence of contrast-induced nephropathy (CIN) after administration of low-osmolar (iopamidol 370, 796 mOsm/kg) or isoosmolar (iodixanol 320, 290 mOsm/kg) contrast medium in patients with diabetes and chronic kidney disease undergoing CT.
Two hundred sixty-three patients with moderate to severe chronic kidney disease (estimated glomerular filtration rate [GFR] = 20-59 mL/min/1.73 m(2)) and diabetes mellitus were randomized to receive at least 65 mL of iopamidol 370 or iodixanol 320 for a CT procedure. Serum creatinine levels were measured at baseline and 48-72 hours after contrast administration. CIN was defined as an increase in the serum creatinine level after contrast administration of >or= 25% from the baseline level. The incidence of CIN in the total study population and the incidence of CIN in patients at increased risk for CIN were compared using Fisher's exact test.
Two hundred forty-eight patients were included in the CIN analysis: 125 receiving iopamidol 370 and 123 receiving iodixanol 320. Study population demographics were comparable, as was baseline renal function (estimated GFR = 47.6 mL/min/1.73 m(2) for the iopamidol 370 group vs 49.9 mL/min/1.73 m(2) for the iodixanol 320 group; p = 0.16). Increases in the serum creatinine value of >or= 25% occurred in seven patients (5.6%) receiving iopamidol 370 and in six patients (4.9%) receiving iodixanol 320 (95% CI, -4.8% to 6.3%; p = 1.0). The mean serum creatinine change from the baseline level was 0.04 mg/dL in both groups (analysis of covariance, p = 0.80). In patients with a baseline serum creatinine value of >or= 2.0 mg/dL, baseline estimated GFR of <or= 40 mL/min/1.73 m(2), or those receiving > 140 mL of contrast medium, the incidence of CIN was low and comparable between the two study groups (p = 1.0 in all instances).
The incidence of CIN in patients with diabetes and chronic kidney disease receiving IV contrast medium was not significantly different after CT using iopamidol 370 or iodixanol 320.
Full-text · Article · Jul 2008 · American Journal of Roentgenology
[Show abstract][Hide abstract] ABSTRACT: The higher relaxivity of gadobenate dimeglumine compared with gadodiamide is potentially advantageous for contrast-enhanced brain MR imaging. This study intraindividually compared 0.1-mmol/kg doses of these agents for qualitative and quantitative lesion enhancement.
Adult patients with suggested or known brain lesions underwent 2 identical MR imaging examinations at 1.5T, one with gadobenate dimeglumine and the other with gadodiamide. The agents were administered in randomized order separated by 3-14 days. Imaging sequences and postinjection acquisition timing were identical for the 2 examinations. Three blinded readers evaluated images qualitatively for diagnostic information (lesion extent, delineation, morphology, enhancement, and global preference) and quantitatively for contrast-to-noise ratio (CNR).
One hundred thirteen of 138 enrolled patients successfully underwent both examinations. Final diagnoses were intra-axial tumor, metastasis, extra-axial tumor, or other (47, 27, 18, and 21 subjects, respectively). Readers 1, 2, and 3 demonstrated global preference for gadobenate dimeglumine in 63 (55.8%), 77 (68.1%), and 73 (64.6%) patients, respectively, compared with 3, 2, and 3 patients for gadodiamide (P < .0001, all readers). Highly significant (P < .0001, all readers) preference for gadobenate dimeglumine was demonstrated for all qualitative end points and for CNR (increases of 23.3%-34.7% and 42.4%-48.9% [spin-echo and gradient-refocused echo sequences, respectively] for gadobenate dimeglumine compared with gadodiamide). Inter-reader agreement was good for all evaluations (kappa = 0.47-0.69). Significant preference for gadobenate dimeglumine was demonstrated for all lesion subgroup analyses.
Significantly greater diagnostic information and lesion enhancement are achieved on brain MR imaging with 0.1-mmol/kg gadobenate dimeglumine compared with gadodiamide at an equivalent dose.
Full-text · Article · Jul 2008 · American Journal of Neuroradiology
[Show abstract][Hide abstract] ABSTRACT: PURPOSE
Treatment of patients with brain metastases is based on accurate assessment of the number, size, and location of enhancing lesions, each of which are determined by application of a gadolinium-based contrast agent. We performed a prospective study to compare gadopentetate dimeglumine with the high relaxivity agent gadobenate dimeglumine for enhancement and conspicuity of intra-axial metastases.
METHOD AND MATERIALS
Patients with confirmed intra-axial brain metastases underwent two complete MR examinations at 1.5T, one performed with 0.1 mmol/kg bodyweight gadobenate dimeglumine and the other with an identical dose of gadopentetate dimeglumine. Contrast agents were given at 2 mL/sec in randomized order with an interval between examinations of 2-7 days. Acquisition parameters and post-dose acquisition times were identical. Three expert readers evaluated images in a blinded manner for lesion border delineation, definition of disease extent, visualization of lesion internal morphology, lesion contrast enhancement and global preference. Quantitative lesion enhancement (% enhancement, lesion-to-brain ratio [LBR] and contrast-to-noise ratio [CNR]) was determined.
Thirty seven patients were included in this study. Quantitative enhancement was significantly greater after gadobenate dimeglumine (% enhancement: p≤0.013; LBR: p≤0.002; CNR: p≤0.04). Contrast enhancement of metastatic lesions was preferred in 49%, 57%, and 68% of subjects after Gd-BOPTA compared with 5%, 8%, and 10% of subjects after gadopentetate dimeglumine (readers 1, 2, 3, respectively). Similar improvements were noted for global preference and for all other qualitative parameters. Reader agreement was good for all evaluations (up to κ=0.55; 67.6%).
In blinded quantitative and qualitative assessments, enhancement and visualization of brain metastases was significantly improved with use of the high relaxivity contrast agent gadobenate dimeglumine.
For patients with CNS metastatic disease, better contrast enhancement may translate into improved treatment decision-making based on a more accurate assessment of the number, size, and location of met
[Show abstract][Hide abstract] ABSTRACT: PURPOSE
To evaluate the safety and efficacy of gadobenate dimeglumine in children using an open label multi-center phase-III study design.
METHOD AND MATERIALS
Subjects between the ages of 2 to 17 years with known or highly suspected CNS disease referred for cranial or spinal MR examination requiring an injection of MR contrast agent were included in the study at one of 6 centers worldwide. For each subject, informed consent was obtained from a responsible parent or guardian. Safety monitoring included a history and physical examination, and pre- and post-dose monitoring of vitals signs, serial 12-lead electrocardiograms (ECG), and blood and urine samples. Gadobenate dimeglumine (MultiHance, Bracco) was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) at a rate of ≤2 mL/sec followed by injection of normal saline. Pre-dose (T1wSE, T2wFSE, and FLAIR sequences) and post-dose (T1wSE ) images were evaluated for lesion enhancement, lesion border delineation, and visualization of internal morphology. Adverse event monitoring was performed for 72 hours and all study subjects were followed up at 30 days to determine final diagnosis.
To date, 41 children with brain or spinal disease have been studied. Gd-BOPTA was well tolerated by all subjects with no clinically significant or serious adverse events reported. No clinically meaningful changes in laboratory or ECG parameters have been observed during the study period. In patients with enhancing lesions, assessment of lesion border delineation, definition of disease extent, visualization of lesion internal morphology and lesion contrast enhancement were considered good to excellent in all subjects.
Gadobenate dimeglumine is a safe and effective MR contrast agent for use in the evaluation of CNS lesions in children.
Gadobenate dimeglumine (Gd-BOPTA) is a high relaxivity contrast agent that has been shown to result in improved enhancement of CNS lesions in adults, but its application in the pediatric population is
[Show abstract][Hide abstract] ABSTRACT: The goal in this article was to compare 0.1 mmol/kg doses of gadobenate dimeglumine (Gd-BOPTA) and gadopentetate dimeglumine, also known as gadolinium diethylenetriamine pentaacetic acid (Gd-DTPA), for enhanced magnetic resonance (MR) imaging of intraaxial brain tumors.
Eighty-four patients with either intraaxial glioma (47 patients) or metastasis (37 patients) underwent two MR imaging examinations at 1.5 tesla, one with Gd-BOPTA as the contrast agent and the other with Gd-DTPA. The interval between fully randomized contrast medium administrations was 2 to 7 days. The T1-weighted spin echo and T2-weighted fast spin echo images were acquired before administration of contrast agents and T1-weighted spin echo images were obtained after the agents were administered. Acquisition parameters and postinjection acquisition times were identical for the two examinations in each patient. Three experienced readers working in a fully blinded fashion independently evaluated all images for degree and quality of available information (lesion contrast enhancement, lesion border delineation, definition of disease extent, visualization of the lesion's internal structures, global diagnostic preference) and quantitative enhancement (that is, the extent of lesion enhancement after contrast agent administration compared with that seen before its administration [hereafter referred to as percent enhancement], lesion/brain ratio, and contrast/noise ratio). Differences were tested with the Wilcoxon signed-rank test. Reader agreement was assessed using kappa statistics. Significantly better diagnostic information/imaging performance (p < 0.0001, all readers) was obtained with Gd-BOPTA for all visualization end points. Global preference for images obtained with Gd-BOPTA was expressed for 42 (50%), 52 (61.9%), and 56 (66.7%) of 84 patients (readers 1, 2, and 3, respectively) compared with images obtained with Gd-DTPA contrast in four (4.8%), six (7.1%), and three (3.6%) of 84 patients. Similar differences were noted for all other visualization end points. Significantly greater quantitative contrast enhancement (p < 0.04) was noted after administration of Gd-BOPTA. Reader agreement was good (kappa > 0.4).
Lesion visualization, delineation, definition, and contrast enhancement are significantly better after administration of 0.1 mmol/kg Gd-BOPTA, potentially allowing better surgical planning and follow up and improved disease management.
Full-text · Article · Apr 2007 · Journal of Neurosurgery
[Show abstract][Hide abstract] ABSTRACT: PURPOSE
This presentation will demonstrate a method that increases the sensitivity of detecting abnormalities on PACS systems using a "blink" method to alternate new and prior medical images digitally upon each other rather than simply comparing them visually in the traditional side-by-side or up-down fashion.
METHOD AND MATERIALS
Two radiologists were separately presented with 80 pairs of images containing 246 abnormalities in conventional series and stack formats typical of contemporary PACS interpretation style. Each pair of images was either plain CR images, CT images or MRI images obtained on the same patient at different times. Each observer was asked to note abnormalities and any changes between the old and the new images. These images were subsequently viewed separately by the same radiologists using the digital blink comparator technique in which the old and new images were rapidly superimposed upon each other in a fashion which caused changes to appear to "blink" on and off in front of the interpreter with no need to turn his head or move his eyes back and forth.
The two radiologists detected 185 and 197 abnormalities respectively using conventional PACS interpretation techniques. Following the use of the digital blink comparator technique, the radiologists detected 223 and 232 abnormalities respectively. This resulted in an improved detection rate of 20.5% and 17.8% respectively.
The use of the digital blink comparator results in significant improvement in the ability of a radiologist to detect new lesions and/or changes when comparing new and prior studies.
By taking advantage of human physiological and psychological mechanisms, the digital blink comparator technique helps radiologists detect and evaluate lesions more accurately.
[Show abstract][Hide abstract] ABSTRACT: To prospectively compare gadobenate dimeglumine with gadopentetate dimeglumine (0.1 mmol per kilogram body weight) for enhanced magnetic resonance (MR) imaging of central nervous system (CNS) lesions.
This study was HIPAA-compliant at U.S. centers and was conducted at all centers according to the Good Clinical Practice standard. Institutional review board and regulatory approval were granted; written informed consent was obtained. Seventy-nine men and 78 women (mean age, 50.5 years +/- 14.4 [standard deviation]) were randomized to group A (n = 78) or B (n = 79). Patients underwent two temporally separated 1.5-T MR imaging examinations. In randomized order, gadobenate followed by gadopentetate was administered in group A; order of administration was reversed in group B. Contrast agent administration (volume, speed of injection), imaging parameters before and after injection, and time between injections and postinjection acquisitions were identical for both examinations. Three blinded neuroradiologists evaluated images by using objective image interpretation criteria for diagnostic information end points (lesion border delineation, definition of disease extent, visualization of internal morphologic features of the lesion, enhancement of the lesion) and quantitative parameters (percentage of lesion enhancement, contrast-to-noise ratio [CNR]). Overall diagnostic preference in terms of lesion conspicuity, detectability, and diagnostic confidence was assessed. Between-group comparisons were performed with Wilcoxon signed rank test.
Readers 1, 2, and 3 demonstrated overall preference for gadobenate in 75, 89, and 103 patients, compared with that for gadopentetate in seven, 10, and six patients, respectively (P < .0001). Significant (P < .0001) preference for gadobenate was demonstrated for diagnostic information end points, percentage of lesion enhancement, and CNR. Superiority of gadobenate was significant (P < .001) in patients with intraaxial and extraaxial lesions.
Gadobenate compared with gadopentetate at an equivalent dose provides significantly better enhancement and diagnostic information for CNS MR imaging.
[Show abstract][Hide abstract] ABSTRACT: The safety and diagnostic efficacy of MultiHance (gadobenate dimeglumine) in the central nervous system (CNS) were evaluated in a double-blind, multicenter, phase III clinical trial.
Two hundred five patients highly suspected of having a CNS lesion (by previous imaging exam) were enrolled at 16 sites in the United States. Patients were randomized to one of three incremental dosing regimens. Magnetic resonance imaging with Omniscan (gadodiamide) at doses of 0.1 and 0.3 mmol/kg was compared with MultiHance (gadobenate dimeglumine) at doses of 0.05 and 0.15 mmol/kg and at 0.1 and 0.2 mmol/kg.
Compared with predose images alone, efficacy was demonstrated in each of the gadobenate dimeglumine and gadodiamide groups (single and cumulative doses) as indicated by the level of diagnostic information, number of lesions detected, and contrast-to-noise ratio measurements. The level of diagnostic information from gadobenate dimeglumine at 0.1 mmol/kg was equivalent to that with gadodiamide at the same dose. One of the two blinded reviewers found equivalence between the gadobenate dimeglumine 0.05 mmol/kg dose and gadodiamide at 0.1 mmol/kg. Both reviewers found the level of diagnostic information to be equivalent after the second dose of contrast for all three dosing regimens. The cumulative doses of gadobenate dimeglumine were well tolerated and as safe as gadodiamide.
Gadobenate dimeglumine is comparable to gadodiamide in terms of safety and efficacy for imaging of CNS lesions, with a possible advantage in imaging applications owing to enhanced T1 relaxivity.
No preview · Article · Mar 2001 · Investigative Radiology
[Show abstract][Hide abstract] ABSTRACT: The objective of the two pivotal phase 3 studies was to evaluate the safety and efficacy of OptiMARK (Gd-DTPA-bis(methoxyethylamide) [Gd-DTPA-BMEA]) compared with Magnevist (Gd-DTPA) in magnetic resonance imaging of the central nervous system.
Two multicenter, randomized, double-blind, parallel group studies were conducted in 395 patients with known or suspected central nervous system pathology. Subjects were randomized to receive a single 0.1 mmol/kg intravenous injection of either Gd-DTPA-BMEA or Gd-DTPA. The safety of Gd-DTPA-BMEA and Gd-DTPA was monitored for up to 72 hours after study drug administration. Precontrast and postcontrast administration magnetic resonance scans were acquired using identical imaging planes and techniques.
No deaths or unexpected adverse events were reported in either group. A comparison of adverse events by intensity and relation demonstrated no statistically significant differences between the two groups. Gd-DTPA-BMEA and Gd-DTPA were equivalent with respect to confidence in diagnosis, conspicuity, and border delineation.
Gd-DTPA-BMEA and Gd-DTPA demonstrated comparable efficacy profiles, and the safety profiles were considered similar.
No preview · Article · Aug 2000 · Investigative Radiology