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1.
Ann Intensive Care ; 10(1): 62, 2020 May 24.
Article in English | MEDLINE | ID: mdl-32449053

ABSTRACT

BACKGROUND: No recommendation exists about the timing and setting for tracheal intubation and mechanical ventilation in septic shock. PATIENTS AND METHODS: This prospective multicenter observational study was conducted in 30 ICUs in France and Spain. All consecutive patients presenting with septic shock were eligible. The use of tracheal intubation was described across the participating ICUs. A multivariate analysis was performed to identify parameters associated with early intubation (before H8 following vasopressor onset). RESULTS: Eight hundred and fifty-nine patients were enrolled. Two hundred and nine patients were intubated early (24%, range 4.5-47%), across the 18 centers with at least 20 patients included. The cumulative intubation rate during the ICU stay was 324/859 (38%, range 14-65%). In the multivariate analysis, seven parameters were significantly associated with early intubation and ranked as follows by decreasing weight: Glasgow score, center effect, use of accessory respiratory muscles, lactate level, vasopressor dose, pH and inability to clear tracheal secretions. Global R-square of the model was only 60% indicating that 40% of the variability of the intubation process was related to other parameters than those entered in this analysis. CONCLUSION: Neurological, respiratory and hemodynamic parameters only partially explained the use of tracheal intubation in septic shock patients. Center effect was important. Finally, a vast part of the variability of intubation remained unexplained by patient characteristics. Trial registration Clinical trials NCT02780466, registered on May 23, 2016. https://clinicaltrials.gov/ct2/show/NCT02780466?term=intubatic&draw=2&rank=1.

2.
Radiologe ; 59(4): 359-368, 2019 Apr.
Article in German | MEDLINE | ID: mdl-30887087

ABSTRACT

BACKGROUND: Numerous clinical MRI studies have been published that describe an association between the repeated administration of (linear) gadolinium-based contrast agents and increased signal intensity in certain brain areas. In November 2017, the European Commission suspended the use of some of these contrast agents. OBJECTIVES: The background for this decision, both regulatory and scientific, are presented and discussed. MATERIALS AND METHODS: The regulatory decisions are evaluated and the clinical and preclinical literature is discussed. RESULTS: Differences in the structure and stability of gadolinium-based contrast agent molecules explain the observed increased signal intensities in individual brain regions (e. g. dentate nucleus) after administration of multiple doses of linear contrast agents. This phenomenon was not observed after administration of multiple doses of macrocyclic contrast agents. Preclinical studies have confirmed these results. CONCLUSION: To date, no clinical symptoms have been confirmed to be associated with the increased signal intensity or gadolinium presence in the brain.


Subject(s)
Contrast Media , Gadolinium , Brain , Magnetic Resonance Imaging , Retrospective Studies
3.
Acta Radiol ; 47(1): 15-23, 2006 Feb.
Article in English | MEDLINE | ID: mdl-16498928

ABSTRACT

PURPOSE: To evaluate the ability of contrast-enhanced magnetic resonance imaging (MRI) with Gd-EOB-DTPA in comparison with non-enhanced imaging and spiral computed tomography (CT) to provide additional information for classification and characterization of hepatocellular carcinoma. MATERIAL AND METHODS: Forty patients with histopathology-proven hepatocellular carcinoma were selected for this subgroup analysis from a phase-III multicenter study in 235 patients with known or suspected liver lesions. The primary analysis was comparison of the proportion of hepatocellular carcinoma correctly classified and characterized by combined pre-/post-contrast MRI compared with pre-contrast MRI alone or with spiral CT. All images were evaluated on site, and in a blinded reading by three independent readers off site. RESULTS: In the on-site evaluation, the lesions were correctly classified as a malignant tumor with combined MRI in 90.3%, with pre-contrast imaging alone in 82.9% and with spiral CT in 87.8% (n.s.). The proportion of correct characterization (lesion type diagnosis) with combined MRI was 85.4%, 75.6% for pre-contrast imaging, and 77.5% for spiral CT (n.s.), respectively. In the blinded reading, one reader showed a significant increase in the proportion of correctly characterized lesions by 27% (P<0.05). The other two readers showed a reduction in the proportion of correct characterization by 12% and 15%, respectively (n.s.). CONCLUSION: With regard to lesion classification, no difference was found between combined pre-/post-contrast MRI and spiral CT. A non-significant trend in favor of Gd-EOB-DTPA-enhanced MRI with regard to characterization of hepatocellular carcinoma was found, although the CT scans were not optimized as the MRI scans.


Subject(s)
Carcinoma, Hepatocellular/diagnosis , Contrast Media/administration & dosage , Gadolinium DTPA , Liver Neoplasms/diagnosis , Magnetic Resonance Imaging/methods , Adult , Aged , Aged, 80 and over , Carcinoma, Hepatocellular/classification , Europe , Female , Humans , Image Enhancement/methods , Liver/diagnostic imaging , Liver/pathology , Liver Neoplasms/classification , Male , Middle Aged , Observer Variation , Prospective Studies , Reproducibility of Results , Tomography, Spiral Computed/methods
5.
Skeletal Radiol ; 32(1): 1-12, 2003 Jan.
Article in English | MEDLINE | ID: mdl-12525938

ABSTRACT

OBJECTIVE: A meta-analysis was carried out of clinical trials published between 1987 and 2001 in respect of the clinical pharmacology and safety as well as the diagnostic efficacy of gadolinium-DTPA (Gd-DTPA) for direct intra-articular injection before MRI examination. DESIGN: Scientific papers (clinical, postmortem and experimental studies) and information from the manufacturer regarding intra-articular injection of Gd-DTPA that addressed questions of mode of action, optimal concentration and dose, elimination and safety were reviewed. Clinical studies were classified according to their study design. The sensitivity, specificity and accuracy of MR arthrography (MRA) were compared with a "gold standard" (arthroscopy, arthrotomy) and other radiological evidence for different joints. RESULTS: Fifty-two clinical studies of the overall 112 studies addressed aspects of diagnostic efficacy of MRA in patients or in healthy volunteers. The shoulder was the most assessed joint (29 of 52 studies). Good (>80%) or even excellent (90-100%) sensitivity, specificity and accuracy were found for MRA in most indications, especially for the shoulder and knee joints and induced extension of rotator cuff lesions, labrum abnormalities and postoperative meniscal tears. Two millimoles per liter has proven to be the best concentration for intra-articular administration of Gd-DTPA. After passive complete diffusion from the joint within 6-24 h, complete and rapid renal elimination takes place after intra-articular injection. Local safety proved to be excellent after intra-articular administration of Gd-DTPA. Regarding systemic tolerance almost no side effects have been reported, but the same safety considerations apply for intra-articular administration of Gd-DTPA as for intravenous injection. CONCLUSIONS: The diagnostic efficacy of intra-articular MRA in most clinical conditions affecting major joints is greater than that of plain MRI. In some diagnostic problems MRA achieves almost the same sensitivity and specificity as the surgical gold standard. Given a sterile application, the intra-articular administration of Gd-DTPA in a concentration of 2 mmol/l prior to MRI is a safe procedure.


Subject(s)
Arthrography , Contrast Media/pharmacology , Gadolinium DTPA/pharmacology , Joint Diseases/diagnosis , Magnetic Resonance Imaging , Clinical Trials as Topic , Humans , Sensitivity and Specificity , Statistics, Nonparametric
6.
Rofo ; 173(11): 1034-40, 2001 Nov.
Article in German | MEDLINE | ID: mdl-11704914

ABSTRACT

PURPOSE: To evaluate the clinical value of the renal clearance using MR imaging with different doses of gadolinium ethoxybenzyl-DTPA (Gd-EOB-DTPA) in comparison to gadolinium DTPA (Gd-DTPA). MATERIAL AND METHODS: In a double-blind and randomized clinical phase II study. MR imaging at 1.5 T was performed in 61 patients with five different doses of Gd-EOB-DTPA (3, 6, 12.5, 25 and 50 micromol/kg b. w. as a bolus injection). The study protocol comprised T(1)- and T(2)-weighted spin-echo magnetic resonance and two-dimensional fast low-angle shot imaging before and at increasing intervals for up to 45 min after injection of Gd-EOB-DTPA. These images were compared with Gd-DTPA-enhanced imaging (0.1 mmol/kg b. w. as a bolus injection). RESULTS: After bolus injection of the hepatobiliary MR contrast agent Gd-EOB-DTPA a renal elimination was observed. Immediately after the injection of Gd-EOB-DTPA until the eighth minute a corticomedullary enhancement of the kidney was conspicuous. After the fourth minute a contrast enhancement could be seen in the renal pelvis. The best enhancement was noted after 20 minutes in the FLASH GRE and T(1)-weighted images with good pelvicaliceal contrast. After 45 minutes an outflow of Gd-EOB-DTPA into the ureter could be observed. CONCLUSION: In addition to the hepatobiliary secretion Gd-EOB-DTPA appears useful for the evaluation of renal structures and renal function on account of the renal excretion without diuretic preparation of the patients.


Subject(s)
Contrast Media , Gadolinium DTPA/pharmacokinetics , Kidney/metabolism , Magnetic Resonance Imaging , Urography/methods , Adult , Aged , Aged, 80 and over , Animals , Contrast Media/administration & dosage , Contrast Media/pharmacokinetics , Female , Gadolinium DTPA/administration & dosage , Gallbladder/metabolism , Humans , Kidney/physiology , Liver/metabolism , Male , Middle Aged , Models, Theoretical , Rats , Time Factors
7.
Forensic Sci Int ; 122(2-3): 107-23, 2001 Nov 01.
Article in English | MEDLINE | ID: mdl-11672964

ABSTRACT

Current blood-level data are presented for drugs and chemicals of toxicologic interest. The data represent an update of previously published compilations of therapeutic, toxic and lethal blood-levels.


Subject(s)
Forensic Medicine , Pharmaceutical Preparations/blood , Toxicology , Dose-Response Relationship, Drug , Humans , Lethal Dose 50 , Reference Values
8.
J Magn Reson Imaging ; 10(1): 65-71, 1999 Jul.
Article in English | MEDLINE | ID: mdl-10398979

ABSTRACT

The purpose of this study was to study temporal changes in signal intensity of liver, spleen, abdominal vessels, and focal liver lesions following iv bolus injection of a superparamagnetic iron oxide (SPIO) using a breath-held three-dimensional magnetic resonance angiography (3D-MRA) sequence. Dynamic SH U 555 A-enhanced 3D-MRA studies were performed in 20 patients with focal liver lesions. Sequential coronal 3D-MRA-FISP scans were acquired (TR 5.0 msec, TE 2.0 msec, flip angle 25 degrees, 140 x 256 matrix, and 80 mm slab) within 15 seconds. Scanning was started immediately after bolus injection of 10 micromol Fe/kg bodyweight and was repeated at multiple time points (baseline and 30, 60, 90, 120, 180, 240, 300, 360, and 420 seconds). Signal intensity values of liver, focal liver lesions, spleen, the portal venous system, the abdominal aorta, and the inferior vena cava were obtained to calculate relative enhancement (ENH = [SI post - SI pre]/SI pre x 100). Visibility of vessels was assessed by consensus of two readers. Signal enhancement within abdominal vessels peaked during the first pass; however, significant signal enhancement was still present 420 seconds following injection. The liver and the spleen also demonstrated a biphasic enhancement pattern with prolonged parenchymal enhancement. Dynamic MRA with bolus injectable SH U 555 A is clinically feasible, and significant vessel enhancement can be achieved even at the dose of 10 micromol Fe/kg bodyweight. However, further refinements are required to improve contrast effects.


Subject(s)
Abdomen , Aorta , Contrast Media , Iron , Liver Neoplasms/diagnosis , Liver/blood supply , Magnetic Resonance Angiography , Oxides , Spleen/blood supply , Dextrans , Female , Ferrosoferric Oxide , Humans , Image Processing, Computer-Assisted , Liver/pathology , Magnetite Nanoparticles , Male , Middle Aged , Neoplasm Metastasis , Portal System/pathology , Spleen/pathology
9.
Development ; 126(9): 1793-803, 1999 May.
Article in English | MEDLINE | ID: mdl-10101114

ABSTRACT

Mitosis in most Drosophila cells is triggered by brief bursts of transcription of string (stg), a Cdc25-type phosphatase that activates the mitotic kinase, Cdk1 (Cdc2). To understand how string transcription is regulated, we analyzed the expression of string-lacZ reporter genes covering approximately 40 kb of the string locus. We also tested protein coding fragments of the string locus of 6 kb to 31.6 kb for their ability to complement loss of string function in embryos and imaginal discs. A plethora of cis-acting elements spread over >30 kb control string transcription in different cells and tissue types. Regulatory elements specific to subsets of epidermal cells, mesoderm, trachea and nurse cells were identified, but the majority of the string locus appears to be devoted to controlling cell proliferation during neurogenesis. Consistent with this, compact promotor-proximal sequences are sufficient for string function during imaginal disc growth, but additional distal elements are required for the development of neural structures in the eye, wing, leg and notum. We suggest that, during evolution, cell-type-specific control elements were acquired by a simple growth-regulated promoter as a means of coordinating cell division with developmental processes, particularly neurogenesis.


Subject(s)
Drosophila Proteins , Drosophila/embryology , Drosophila/genetics , Embryo, Nonmammalian/physiology , Gene Expression Regulation, Developmental , Phosphoprotein Phosphatases/genetics , Phosphoprotein Phosphatases/metabolism , Protein Tyrosine Phosphatases , Regulatory Sequences, Nucleic Acid , Transcription, Genetic , Animals , Cell Cycle Proteins/genetics , Cell Cycle Proteins/metabolism , Cell Division , Embryo, Nonmammalian/cytology , Embryonic Induction , Mitosis , Nervous System/embryology , Promoter Regions, Genetic , cdc25 Phosphatases
10.
Rofo ; 168(3): 228-36, 1998 Mar.
Article in German | MEDLINE | ID: mdl-9551108

ABSTRACT

PURPOSE: Evaluation of the diagnostic usefulness of the T1-effect of Resovist (SPIO) for dynamic MRI of the liver. METHOD: In-vitro measurements of a dilution series with T1-weighted FLASH and SE sequences and investigation of 25 patients with known focal liver lesions with a T2-weighted TSE sequence and a dynamic T1-FLASH sequence. RESULTS: T1-weighted MRI with Resovist in vitro showed a positive enhancement at low concentrations and a negative enhancement at higher concentrations. In-vivo T1-weighted dynamic MRI liver parenchyma demonstrated a positive enhancement 30 s post contrast, followed by a continuous slope of signal intensity and a negative enhancement (> or = 60 s). Spleen, portal venous vessels and haemangiomas showed an early increase in signal intensity followed by a decreasing positive enhancement, but without negative enhancement. During the perfusion phase metastases showed a small but not significant increase in signal intensity. In 80% a positive ring enhancement could be observed around metastases. CONCLUSION: Resovist exhibits a diagnostically useful T1-effect. An evaluation of the perfusion of focal liver lesions during the distribution phase is possible with dynamic T1-weighted MRI. This approach may further improve characterisation of focal liver lesions.


Subject(s)
Contrast Media , Iron , Liver Neoplasms/diagnosis , Liver Neoplasms/secondary , Liver/pathology , Magnetic Resonance Imaging/methods , Oxides , Phantoms, Imaging , Adult , Aged , Dextrans , Female , Ferrosoferric Oxide , Hemangioma/diagnosis , Hemangioma/pathology , Humans , Magnetite Nanoparticles , Male , Middle Aged , Pancreatic Neoplasms/diagnosis , Pancreatic Neoplasms/pathology , Portal System/pathology , Reproducibility of Results , Spleen/pathology
12.
Radiology ; 206(2): 365-71, 1998 Feb.
Article in English | MEDLINE | ID: mdl-9457187

ABSTRACT

PURPOSE: To evaluate the efficacy of SH U 555 A in three doses for magnetic resonance (MR) imaging in the liver and to establish the best postinjection time point for liver MR imaging. MATERIALS AND METHODS: Pre- and postcontrast image sets obtained in 169 patients after injection of SH U 555 A (randomly, 4, 8, or 16 mumol of iron per kilogram of body weight). Three blinded readers evaluated the precontrast and 10- and 40-minute postcontrast MR images of 54, 58, and 57 patients, respectively. RESULTS: Statistically significant differences were observed in diagnostic confidence between images obtained with a dose of 4 or 16 mumol Fe/kg (P = .011) and in good or excellent improvement, respectively, in delineation of lesions on 10-minute postcontrast images (P = .001). No apparent differences in the efficacy evaluation were seen between the 10- and 40-minute postcontrast imaging time points. CONCLUSION: There was a dose-dependent postcontrast improvement in evaluated efficacy parameters (diagnostic confidence, visual evaluations) after injection of SH U 555 A. Accumulation phase imaging could begin as early as 10 minutes after administration.


Subject(s)
Contrast Media/administration & dosage , Iron/administration & dosage , Liver Neoplasms/diagnosis , Liver/pathology , Magnetic Resonance Imaging/methods , Oxides/administration & dosage , Dextrans , Dose-Response Relationship, Drug , Evaluation Studies as Topic , Female , Ferrosoferric Oxide , Humans , Injections, Intravenous , Liver Diseases/diagnosis , Magnetite Nanoparticles , Male , Middle Aged , Suspensions , Time Factors
13.
J Magn Reson Imaging ; 7(6): 945-9, 1997.
Article in English | MEDLINE | ID: mdl-9400835

ABSTRACT

The purpose of this study was to investigate whether MR angiography (MRA) of the portal venous system may be improved by means of superparamagnetic iron oxides (SPIOs) during accumulation phase imaging and to study the underlying contrast mechanisms. MRA of the portal venous system was performed on 48 patients before and after intravenous injection of a new SPIO (Resovist, Schering AG, Berlin, Germany). Resovist, as a predominantly liver parenchymal darkening agent on T2-weighted MR images with uptake into the reticuloendothelial cell system, was administered intravenously by bolus injection of 8 to 12 micromol Fe/kg body weight. Patients were scanned with breath-hold coronal and axial two-dimensional (2D) time of flight (TOF) MRA (TR = 31.0 msec, TE = 9.8 msec, flip angle (FA) = 50 degrees, and 6.9-second acquisition time per section) sequences. Signal intensity values of liver parenchyma, the portal venous system, and background were obtained for quantitative analysis. The clinical relevance of additional plain and contrast-enhanced MRA studies for surgical planning was assessed by independent reading of three readers. Liver signal-to-noise ratio (SNR) significantly decreased following iv injection of Resovist; however, SNR values of the portal veins or hepatic veins did not change significantly. Visibility of the portal venous system improved significantly (tertiary branches visible: pre in 15.2% versus post in 87.0% of patients). Resovist-enhanced 2D-TOF MRA may improve planning of liver resections by better demonstrating the relationship of central liver lesions and vessels on source images. The decrease in liver SNR at a constant vessel SNR after iv injection of Resovist improves MRA of the liver. SPIO-enhanced 2D-TOF MRA scans are superior to plain 2D-TOF MRA studies and may be added for the workup of preoperative patients.


Subject(s)
Contrast Media , Iron , Liver Diseases/diagnosis , Magnetic Resonance Angiography/methods , Oxides , Portal Vein , Dextrans , Female , Ferrosoferric Oxide , Humans , Magnetite Nanoparticles , Male , Middle Aged , Suspensions
14.
Radiology ; 204(3): 749-56, 1997 Sep.
Article in English | MEDLINE | ID: mdl-9280254

ABSTRACT

PURPOSE: To evaluate the safety, efficacy, and pharmacodynamic properties of a new superparamagnetic parenteral iron oxide contrast agent for magnetic resonance (MR) imaging. MATERIALS AND METHODS: Thirty-six patients with liver lesions received a bolus injection of Resovist (SH U 555 A; Schering, Berlin, Germany) at a dose of 4, 8, or 16 micromol iron per kilogram body weight (micromol Fe/kg). Fast low-angle shot, spin-echo, and turbo gradient spin-echo MR images were obtained before and 10, 40, and 70 minutes after injection. Blood samples were obtained, vital signs were monitored, and adverse events were recorded. Lesion detection was assessed by two independent, blinded readers. RESULTS: No drug-related adverse events occurred. Serum iron and ferritin levels were increased at all dose levels. Partial thromboplastin time increased and factor XI level decreased 4 hours after injection of 16 micromol Fe/kg. Lesion detection and diagnostic confidence were increased in patients who received 4 or 8 micromol Fe/kg, with no further increase with a 16-micromol dose. CONCLUSION: Resovist is safe and effective. The best MR imaging results were obtained 40 minutes after injection of 8 micromol Fe/kg.


Subject(s)
Contrast Media , Iron , Liver Diseases/diagnosis , Liver/pathology , Magnetic Resonance Imaging , Oxides , Adult , Aged , Aged, 80 and over , Contrast Media/adverse effects , Contrast Media/pharmacokinetics , Dextrans , Female , Ferritins/blood , Ferrosoferric Oxide , Humans , Iron/adverse effects , Iron/blood , Iron/pharmacokinetics , Liver Neoplasms/diagnosis , Magnetite Nanoparticles , Male , Middle Aged , Oxides/adverse effects , Oxides/pharmacokinetics
15.
J Magn Reson Imaging ; 7(3): 490-4, 1997.
Article in English | MEDLINE | ID: mdl-9170032

ABSTRACT

The purpose of this study was to investigate whether extracellular MR contrast agents or intracellular liver-specific MR contrast agents may enable the assessment of liver reperfusion injury. Ischemia-related reperfusion was induced in 32 rats using Pringle's maneuver. Pringle's maneuver consisted of cross-clamping of the complete hepatoduodenal ligament for 45 minutes followed by 90 minutes of reperfusion. Two extracellular (gadopentetate dimeglumine and gadobutrol) and two intracellular gadoxetic acid and SH U 555 A) MR contrast agents were evaluated as model agents. Control animals and animals with liver ischemia were used to calculate changes in liver signal enhancement after Pringle's maneuver. Significant changes in liver signal after reperfusion injury were observed only with reticuloendothelial system (RES)-specific SH U 555 A. Liver signal enhancement after Pringle's maneuver with RES-specific SH U 555 A was decreased by 25.4% as compared with the control group. RES-specific contrast agents such as SH U 555 A seem to be more sensitive to ischemia-related dysfunction of the liver than hepatobiliary contrast agents such as gadoxetic acid or extracellular gadolinium chelates at different concentrations because Kupffer cells are more sensitive to liver ischemia than hepatocytes.


Subject(s)
Contrast Media/administration & dosage , Liver/pathology , Meglumine/administration & dosage , Organometallic Compounds/administration & dosage , Pentetic Acid/analogs & derivatives , Reperfusion Injury/diagnosis , Analysis of Variance , Animals , Disease Models, Animal , Drug Combinations , Female , Gadolinium DTPA , Image Enhancement/methods , Male , Pentetic Acid/administration & dosage , Rats , Rats, Wistar , Reference Values , Reperfusion Injury/pathology , Sensitivity and Specificity
16.
Radiology ; 202(2): 399-405, 1997 Feb.
Article in English | MEDLINE | ID: mdl-9015065

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of gadoxetic acid disodium, or Gd-EOB-DTPA, as a tissue-specific hepatobiliary contrast agent at computed tomography (CT) in patients with liver metastases. MATERIALS AND METHODS: Fifteen patients with known liver metastases underwent CT before and at 30, 80, and, in seven cases, 150 minutes after initiation of intravenous infusion of 0.2, 0.35, and 0.5 mmol Gd/kg gadoxetic acid disodium (five patients per dose group). Attenuation in liver tissue and metastases was measured at each time point. Visualization of metastases, bile ducts, and gallbladder was graded subjectively by two investigators aware of the dose administered and the imaging time point. Patients were monitored for adverse events clinically, and numerous laboratory tests were performed over the 24 hours after administration of the contrast material. RESULTS: The net mean increase in liver attenuation with 0.2, 0.35, and 0.5 mmol Gd/kg was 13 HU +/- 4 (standard deviation), 27 HU +/- 6, and 34 HU +/- 8, respectively. Visualization of liver metastases with doses of 0.35 and 0.5 mmol Gd/kg was graded as good or excellent. Visualization of the gallbladder and common bile duct with doses of 0.35 and 0.5 mmol Gd/kg was improved from minimal to excellent in 89% and 57% of patients, respectively, on 80-minute postcontrast scans. No serious adverse events occurred. Four of 15 patients experienced mild or moderate adverse events possibly or probably related to the contrast medium. Levels of aspartate and alanine aminotransferase increased in three patients by 12-26 and 21-48 U/L, respectively, from normal or moderately elevated baseline levels. These changes may be related to the contrast medium or to the metastases. CONCLUSION: Patient tolerance of gadoxetic acid disodium was acceptable, and liver enhancement and visualization of liver lesions and the biliary system was improved at CT.


Subject(s)
Biliary Tract/diagnostic imaging , Contrast Media , Gadolinium DTPA , Liver Neoplasms/diagnostic imaging , Liver Neoplasms/secondary , Liver/diagnostic imaging , Organometallic Compounds , Pentetic Acid/analogs & derivatives , Tomography, X-Ray Computed , Aged , Contrast Media/adverse effects , Female , Gadolinium , Humans , Male , Middle Aged , Organometallic Compounds/adverse effects , Pentetic Acid/adverse effects
17.
Eur Radiol ; 7(2): 275-80, 1997.
Article in English | MEDLINE | ID: mdl-9038130

ABSTRACT

Our objective was to study Gd-EOB-DTPA for the characterization of focal liver lesions by means of dynamic MR imaging. A double-blind and randomized dose-ranging phase-2 clinical trial was performed in 31 patients (liver metastases n = 23, hepatocellular carcinoma n = 4, and hemangioma n = 4) at a field strength of 1.0 Tesla. Gd-EOB-DTPA (Schering AG, Berlin, Germany) was administered as an IV bolus (12.5, 25, or 50 micromol/kg body weight) with dynamic T1-weighted MRI during the distribution and cellular uptake of the contrast agent at multiple time points up to 45 min post contrast. Dynamic changes in tumor signal intensity, tumor-liver contrast, enhancement patterns, side effects, and adverse events were evaluated. Monitoring of vital signs revealed no significant changes during bolus injection of Gd-EOB-DTPA. Liver metastases demonstrated an inhomogeneous uptake of Gd-EOB-DTPA during the distribution phase with a washout effect on delayed images > 3 min and highest tumor-liver contrast 20 and 45 min post contrast. Hepatocellular carcinomas showed prolonged enhancement as compared with metastases and hemangiomas. Hemangiomas exhibited an early peripheral-nodular enhancement with subsequent partial or complete filling, persisting enhancement < 10 min following injection of Gd-EOB-DTPA, and delayed washout as compared with liver metastases. Initial clinical experience suggests that Gd-EOB-DTPA as a bolus injectable hepatobiliary MR contrast agent may offer useful features for the characterization of focal liver lesions.


Subject(s)
Carcinoma, Hepatocellular/diagnosis , Contrast Media , Gadolinium DTPA , Gadolinium , Hemangioma/diagnosis , Liver Neoplasms/secondary , Magnetic Resonance Imaging , Organometallic Compounds , Pentetic Acid/analogs & derivatives , Contrast Media/administration & dosage , Double-Blind Method , Female , Gadolinium/administration & dosage , Humans , Injections, Intravenous , Liver/pathology , Liver Neoplasms/diagnosis , Male , Middle Aged , Organometallic Compounds/administration & dosage , Pentetic Acid/administration & dosage
18.
Rofo ; 167(3): 264-73, 1997 Sep.
Article in German | MEDLINE | ID: mdl-9376555

ABSTRACT

PURPOSE: To analyse characteristics of benign and malignant liver tumours in dynamic and static MR imaging with the superparamagnetic MR contrast medium Resovist. MATERIAL AND METHODS: All 30 patients were examined on a 1.5 Tesla MR unit (Magnetom 63 SP, Siemens AG, Erlangen, Germany) using proton density (PD) weighted (w), T2-weighted-spin-echo, a T1-weighted SE, and a T1-weighted FLASH-2 D gradient echo (GRE) sequence before, during and after the application of Resovist. Dynamic imaging was performed using a T2-weighted GRE-sequence (TurboFLASH; TR/TE = 11/30; flip angle = 10 degrees; Tl = 600 ms). Histopathology revealed benign liver lesions in 8 patients and malignant lesions in 22 patients. RESULTS: Dynamic T2-weighted sequence revealed an early loss of signal intensity in normal liver parenchyma (percentage signal intensity loss (PSIL) = 40.0 +/- 12.2% by 4 mumol Fe/kg, 47.2 +/- 18.8% by 8 mumol Fe/kg and 62.7 +/- 13.0% by 16 mumol Fe/kg), in the spleen, as well as in FNH (PSIL = 49.5 +/- 7.3% by 8 mumol Fe/kg), and regenerating nodules in the first minute after application of Resovist. In two of 4 cases with HCC a short drop in signal intensity was immediately observed after the application, whereas signal intensity remained unchanged in all other malignant liver tumours. Enhanced PDw and T2-weighted SE-sequences revealed an improved detection and delineation of malignant liver lesions versus plain MR imaging. 17 liver lesions of a size lower 10 mm were additionally detected in postcontrast T2-weighted SE-sequences in 4 patients. CONCLUSION: Dynamic and static versus plain MR imaging of primary and secondary liver lesions is markedly improved by the superparamagnetic contrast material Resovist, especially in case of intravenous bolus application of this liver-specific contrast medium.


Subject(s)
Carcinoma, Hepatocellular/diagnosis , Cholangiocarcinoma/diagnosis , Contrast Media , Iron , Liver Neoplasms/diagnosis , Magnetic Resonance Imaging , Oxides , Adult , Aged , Dextrans , Diagnosis, Differential , Female , Ferrosoferric Oxide , Hemangioma/diagnosis , Humans , Liver Neoplasms/secondary , Lymphoma, Non-Hodgkin/diagnosis , Magnetic Resonance Imaging/methods , Magnetite Nanoparticles , Male , Middle Aged , Models, Theoretical , Prospective Studies
19.
Rofo ; 167(6): 591-8, 1997 Dec.
Article in German | MEDLINE | ID: mdl-9465954

ABSTRACT

PURPOSE: The purpose of the study was to investigate the use and safety of Gadobutrol, a new low-osmolar, non-ionic contrast agent for MRI using a total dose of 0.3 mmol/kg b.w. on the basis of a clinical phase 3 study. METHODS: 30 patients with primary brain tumours (n = 15) or cerebral metastases (n = 15) were examined via MRI before and after application of a total of 0.3 mmol/kg b.w. given in two fractions (0.1 and 0.2 mmol/kg b.w.). T2-weighted images were performed before, T1-weighted images before, between and after application of contrast material. RESULTS: In this study one-molar Gadobutrol showed a good tolerance. In half of the cases the contrast between lesion and brain was improved comparing single and triple dose, but this means only a slightly improvement of information for the primary brain tumours compared with single dose. The detected metastatic lesions increased in 40% of the patients after the single dose and in 53% of the patients after cumulative triple dose. There was a consecutive change in therapy in 20% of the patients. CONCLUSION: For the differentiation of primary brain tumours the single dose was sufficient, in metastatic lesions triple dose was essential for the detection or exclusion of multifocality.


Subject(s)
Brain Neoplasms/diagnosis , Contrast Media , Gadolinium , Magnetic Resonance Imaging/methods , Organometallic Compounds , Adenoma/diagnosis , Adult , Aged , Astrocytoma/diagnosis , Brain Neoplasms/secondary , Contrast Media/administration & dosage , Craniopharyngioma/diagnosis , Female , Gadolinium/administration & dosage , Hemangioblastoma/diagnosis , Humans , Male , Meningioma/diagnosis , Middle Aged , Oligodendroglioma/diagnosis , Organometallic Compounds/administration & dosage , Pituitary Neoplasms/diagnosis , Safety
20.
Invest Radiol ; 31(11): 696-708, 1996 Nov.
Article in English | MEDLINE | ID: mdl-8915751

ABSTRACT

RATIONALE AND OBJECTIVES: The authors assess the efficacy of static and dynamic magnetic resonance (MR) imaging using the superparamagnetic iron oxide SHU-555A (Resovist) versus standard dose of gadolinium (Gd)-DTPA in patients with focal liver lesions. METHODS: Magnetic resonance imaging was performed in 30 patients suffering from histopathologically verified malignant (n = 22) and benign (n = 8) liver lesions. T2-weighted conventional and fat-suppressed as well as T1-weighted sequences were used before, during, and after fast intravenous administration of Resovist (1 mL/minute) at three doses of 4, 8, and 16 mumol/kg body weight. One week before the Resovist-enhanced MR imaging study 20 patients underwent Gd-DTPA-enhanced MR imaging. RESULTS: Detection rate was improved for metastatic lesions revealing 36 lesions unenhanced versus 53 focal lesions using Resovist-enhanced MR imaging. Gadolinium-DTPA-enhanced scans showed no additional lesion versus unenhanced and Resovist-enhanced MR imaging. Static and dynamic imaging demonstrated no measurable percentage signal intensity loss (PSIL) using Resovist-enhanced MR imaging versus a percentage enhancement of 79.7% in Gd-DTPA enhanced scans. In the dynamic T2-weighted sequences, hepatocellular carcinoma nodules (n = 4) showed a rapid decrease in signal intensity starting at 44 seconds. Postinfusion of Resovist followed by a low, constant increase in signal intensity. Gadolinium-DTPA enhanced scans showed a percentage enhancement of 73.4 focal nodular hyperplasia (FNH) and hemangioma revealed a strong and early dose-dependent PSIL 44 to 60 seconds postinfusion with a prolonged signal loss for the FNH in the late study. Statistical evaluation revealed a statistically significant superiority of Resovist-enhanced MR imaging concerning the detection and delineation of focal liver lesions compared with unenhanced and Gd-DTPA enhanced scans (P < 0.05). CONCLUSIONS: The fast infusion of the new superparamagnetic contrast agent Resovist shows advantages for dynamic and static MR imaging of focal liver lesions.


Subject(s)
Contrast Media , Gadolinium , Iron , Liver Diseases/diagnosis , Liver Neoplasms/diagnosis , Magnetic Resonance Imaging/methods , Organometallic Compounds , Oxides , Pentetic Acid/analogs & derivatives , Carcinoma, Hepatocellular/diagnosis , Dextrans , Ferrosoferric Oxide , Follow-Up Studies , Gadolinium DTPA , Hemangioma/diagnosis , Humans , Magnetite Nanoparticles , Prospective Studies , Suspensions
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