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1.
Contrast enhanced ultrasound for the diagnosis of liver hemangiomas - results of a Romanian multicentre study.
Sirli, R, Sporea, I, Săndulescu, DL, Popescu, A, Dănilă, M, Săftoiu, A, Spârchez, Z, Badea, R
Medical ultrasonography. 2015;(4):444-50
Abstract
BACKGROUND AND AIM Contrast enhanced ultrasound (CEUS) has been proven to be a reliable method for the characterization of focal liver lesions (FLL). The aim of this paper was to evaluate the performance of CEUS for the diagnosis of liver hemangiomas in a large cohort of patients. MATERIAL AND METHOD We performed a multicentre prospective study which included successive CEUS examinations from fourteen centers from Romania. CEUS examinations were performed in de novo FLL, using low mechanical index ultrasound, following an intravenous bolus of 2.4 ml SonoVue. CEUS was considered conclusive for hemangioma if a typical pattern was present following contrast (centripetal fill in during the arterial phase, hyperenhanced lesion during venous and late phases). In all cases a reference method was available (contrast CT or MRI or biopsy). The trial was registered in clinicaltrials.gov (Identifier NCT01329458). RESULTS During February 2011 - May 2015, 1153 CEUS examinations were performed for the evaluation of de novo FLL. Out of the 1153 de novo FLL, 238 cases were diagnosed as hemangiomas by CEUS (typical enhancing pattern). Contrast CT/MRI and biopsy diagnosed additional 24 hemangiomas. From the 238 cases diagnosed as hemangiomas by CEUS, in 11 the final diagnosis was different. Considering contrast CT/MRI and biopsy as reference methods, CEUS had 90.4% sensitivity, 98.8% specificity, 95.4% positive predictive value, 97.4% negative predictive value, resulting in 96.9% diagnostic accuracy for the diagnosis of hemangiomas. CONCLUSION CEUS is a sensitive and very specific method for the diagnosis of hemangiomas.
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2.
Benefit of Contrast-Enhanced Ultrasound (CEUS) in the Follow-Up Care of Patients with Colon Cancer: A Prospective Multicenter Study.
Bernatik, T, Schuler, A, Kunze, G, Mauch, M, Dietrich, CF, Dirks, K, Pachmann, C, Börner, N, Fellermann, K, Menzel, J, et al
Ultraschall in der Medizin (Stuttgart, Germany : 1980). 2015;(6):590-3
Abstract
PURPOSE According to the German guidelines on colorectal cancer, unenhanced ultrasound is recommended for follow-up. On the other hand, ultrasound and radiology societies specify the use of contrast-enhanced ultrasound for ruling out liver metastases. Studies focusing on the follow-up of cancer patients are lacking. The goal of this multicenter study initiated by the German Ultrasound Society (DEGUM) was to determine the potential benefit of contrast-enhanced ultrasound in the follow-up of patients with colon cancer. MATERIALS AND METHODS Follow-up patients with colon cancer (UICC > IIa) were investigated. As scheduled according to the German guidelines, unenhanced ultrasound was performed followed by contrast-enhanced ultrasound. All liver lesions were recorded. In case of additional metastases detected on contrast-enhanced ultrasound, contrast-enhanced CT, MRI or biopsy was performed to confirm additional liver metastases. RESULTS A total of 45 liver metastases were detected in 26/290 patients (= 9 %) using unenhanced ultrasound. A further 28 metastases were detected on contrast-enhanced ultrasound in these 26 patients. In 18 patients showing no liver metastases, 40 additional metastases were detected on unenhanced ultrasound. This means that 44 patients with a total of 113 liver metastases were detected on contrast-enhanced ultrasound (p = 0.0006). CONCLUSION Contrast-enhanced ultrasound should be recommended in the follow-up of patients with colon cancer in addition to unenhanced ultrasound - the up-to-date standard.
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3.
Detection of hepatocellular carcinoma and liver metastases with BR14: a multicenter phase IIA study.
Hohmann, J, Müller, A, Skrok, J, Wolf, KJ, Martegani, A, Dietrich, CF, Albrecht, T
Ultrasound in medicine & biology. 2012;(3):377-82
Abstract
The study was designed primarily to find the optimal dosage range of BR14 contrast-enhanced ultrasonography (CEUS) to detect malignant focal liver lesions. Secondary objectives were the evaluation of the safety profile and comparison with contrast-enhanced MRI (CE MRI). We studied 25 patients (9 females, 16 males, mean age, 66 years) with known hepatocellular carcinoma or liver metastases at 3 centers over a 3-month period. Each patient underwent a baseline examination and at least 3 CEUS examinations with ascending dose levels (0.25 mL; 1.0 mL; 4.0 mL) of BR14. CE MRI was performed 4 weeks before or after the CEUS examination. Dedicated liver maps were used to record the location, size, and type of detected lesions. Examination quality was documented and safety parameters were assessed. The number of lesions detected by BR14 CEUS increased with dosage, whereas the number of missed lesions and the lesion sizes decreased. Despite the increasing contrast enhancement, substantial differences among dosages were not seen for other image quality parameters. No significant changes were noted in safety parameters and no serious adverse events were reported. We conclude that the recommended dose level of BR14 is between 1 mL and 4 mL; at this dosage, lesion detection is comparable to that of CE MRI.
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4.
Detection and characterization of focal liver lesions: a Japanese phase III, multicenter comparison between gadoxetic acid disodium-enhanced magnetic resonance imaging and contrast-enhanced computed tomography predominantly in patients with hepatocellular carcinoma and chronic liver disease.
Ichikawa, T, Saito, K, Yoshioka, N, Tanimoto, A, Gokan, T, Takehara, Y, Kamura, T, Gabata, T, Murakami, T, Ito, K, et al
Investigative radiology. 2010;(3):133-41
Abstract
OBJECTIVES To prospectively evaluate the safety and efficacy of combined unenhanced and gadoxetic acid disodium (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) imaging compared with unenhanced MR imaging and triphasic contrast-enhanced spiral computed tomography (CT) for the detection and characterization of focal liver lesions. MATERIALS AND METHODS The study was reviewed and approved by the institutional review board at each of the 15 centers involved in the study, and informed written consent was given by all patients. In total, 178 patients with suspected focal hepatic lesions (based, in most patients, on CT, tumor marker and ultrasound examinations) underwent combined MR imaging with a single, rapid injection of Gd-EOB-DTPA 0.025 mmol/kg, including T1-weighted dynamic and delayed MR images 20 to 40 minutes postinjection. Triphasic contrast-enhanced CT, the comparator examination, was performed within 4 weeks of MR imaging. Standard of references (SOR) were resection histopathology and intraoperative ultrasonography, or combined CT during arterial portography and CT hepatic arteriography; in cases where, although the major lesions were treated, some lesion(s) were not treated, follow-up superparamagnetic iron oxide-enhanced MR imaging was additionally performed. All images were assessed for differences in lesion detection and characterization (specific lesion type) by on-site readers and 3, blinded (off-site) reviewers. All adverse events (AEs) occurring within 72 hours after Gd-EOB-DTPA administration were reported. RESULTS Overall, 9.6% of patients who received Gd-EOB-DTPA reported 21 drug-related AEs. A total of 151 patients were included in the efficacy analysis. Combined MR imaging showed statistically higher sensitivity in lesion detection (67.5%-79.5%) than unenhanced MR imaging (46.5%-59.1%; P < 0.05 for all). Combined MR imaging also showed higher sensitivity in lesion detection than CT (61.1%-73.0%), with the results being statistically significant (P < 0.05) for on-site readers and 2 of 3 blinded readers. Higher sensitivity in lesion detection with combined MR imaging compared with CT was also clearly demonstrated in the following subgroups: lesions with a diameter CONCLUSION In this study, hepatocyte-specific Gd-EOB-DTPA was shown to be safe and to improve the detection and characterization of focal hepatic lesions compared with unenhanced MR imaging. When compared with spiral CT, Gd-EOB-DTPA enhanced MRI seems to be beneficial especially for the detection for smaller lesions or hepatocellular carcinoma underlying cirrhotic liver.
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5.
Performance of delayed-enhancement magnetic resonance imaging with gadoversetamide contrast for the detection and assessment of myocardial infarction: an international, multicenter, double-blinded, randomized trial.
Kim, RJ, Albert, TS, Wible, JH, Elliott, MD, Allen, JC, Lee, JC, Parker, M, Napoli, A, Judd, RM, ,
Circulation. 2008;(5):629-37
Abstract
BACKGROUND The identification and assessment of myocardial infarction (MI) are important for therapeutic and prognostic purposes, yet current recommended diagnostic strategies have significant limitations. We prospectively tested the performance of delayed-enhancement magnetic resonance imaging (MRI) with gadolinium-based contrast for the detection of MI in an international, multicenter trial. METHODS AND RESULTS Patients with their first MI were enrolled in an acute (< or = 16 days after MI; n=282) or chronic (17 days to 6 months; n=284) arm and then randomized to 1 of 4 doses of gadoversetamide: 0.05, 0.1, 0.2, or 0.3 mmol/kg. Standard delayed-enhancement MRI was performed before contrast (control) and 10 and 30 minutes after gadoversetamide. For blinded analysis, precontrast and postcontrast MRIs were randomized and then scored for enhanced regions by 3 independent readers not associated with the study. The infarct-related artery perfusion territory was scored from x-ray angiograms separately. In total, 566 scans were performed in 26 centers using commercially available scanners from all major US/European vendors. All scans were included in the analysis. The sensitivity of MRI for detecting MI increased with rising dose of gadoversetamide (P<0.0001), reaching 99% (acute) and 94% (chronic) after contrast compared with 11% before contrast. Likewise, the accuracy of MRI for identifying MI location (compared with infarct-related artery perfusion territory) increased with rising dose of gadoversetamide (P<0.0001), reaching 99% (acute) and 91% (chronic) after contrast compared with 9% before contrast. For gadoversetamide doses > or = 0.2 mmol/kg, 10- and 30-minute images provided equal performance, and peak creatine kinase-MB levels correlated with MRI infarct size (P<0.0001). CONCLUSIONS Gadoversetamide-enhanced MRI using doses of > or = 0.2 mmol/kg is effective in the detection and assessment of both acute and chronic MI. This study represents the first multicenter trial designed to evaluate an imaging approach for detecting MI.
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6.
Contrast enhanced gray-scale sonography in assessment of joint vascularity in rheumatoid arthritis: results from the IACUS study group.
Klauser, A, Demharter, J, De Marchi, A, Sureda, D, Barile, A, Masciocchi, C, Faletti, C, Schirmer, M, Kleffel, T, Bohndorf, K, et al
European radiology. 2005;(12):2404-10
Abstract
The purpose of this study way to assess the value of contrast enhanced gray-scale ultrasound (CEUS) in detection of vascularity in joints of patients with rheumatoid arthritis (RA) in a multicenter study of the International Arthritis Contrast Ultrasound (IACUS) study group. We assessed 113 joints in 113 patients (44 men, 69 women; mean age 51+/-14 years) with clinical diagnosis of RA. Gray-scale ultrasound (US), power Doppler US (PDUS) and CEUS, using a low mechanical index US technique, was performed. CEUS was done by bolus administration of the contrast agent SonoVue (Bracco, Milan, Italy) with a dosage of 4.8-ml SonoVue flushed with 10 ml saline. Detection of joint vascularity was performed for differentiation of active synovitis from inactive intra-articular thickening (synovitis/effusion). With the use of US and PDUS, active synovitis could be differentiated from inactive intra-articular thickening in 68/113 joints (60.1%), whereas CEUS enabled differentiation in 110/113 (97.3%) joints (p<0.0001). Thickness measurement of active synovitis was significantly improved after contrast administration (p=0.008). In conclusion, CEUS improves the differentiation of active synovitis from inactive intra-articular thickening. Since CEUS has shown an ability to improve assessment of vascularized synovial proliferation in RA affected joints, this technique may have further potential in monitoring therapy.
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7.
Improvement of image quality of non-invasive coronary artery imaging with magnetic resonance by the use of the intravascular contrast agent Clariscan (NC100150 injection) in patients with coronary artery disease.
Klein, C, Schalla, S, Schnackenburg, B, Bornstedt, A, Hoffmann, V, Fleck, E, Nagel, E
Journal of magnetic resonance imaging : JMRI. 2003;(6):656-62
Abstract
PURPOSE To assess the feasibility of Clariscan, an intravascular contrast agent, for free breathing, navigator assisted, high resolution, three-dimensional-magnetic resonance coronary angiography (MRCA) in patients, as extracellular contrast agents are unfavorable for the improvement of image quality. MATERIALS AND METHODS MRCA was performed in 10 patients with known coronary artery disease (CAD) with (1-5 mg Fe/kg body weight) and without contrast agent. RESULTS Compared to unenhanced images, Clariscan did not improve signal-to-noise (SNR) or contrast-to-noise ratios (CNR) compared to fat or myocardium in the proximal parts of the coronary arteries. However, when analyzing the peripheral parts (>4 cm from origin), CNR(fat) and CNR(myo) improved up to a factor of 1.81 and 5.85, respectively, at a dose of 3 mg Fe/kg body weight, while SNR did not reach statistical significance. The visible length of the coronary arteries was improved from 49 +/- 18 mm to 73 +/- 33 mm. The proximal diameter was reduced from 3.6 +/- 0.8mm to 3.2 +/- 0.8 mm, representing more closely the diameter of 3.1 +/- 0.7 mm measured by quantitative coronary angiography. Of 11 significant stenoses (>50%), eight were identified in the enhanced compared to six in the unenhanced images. CONCLUSION The use of Clariscan at a dose of 2-3 mg Fe/kg body weight improves image quality of three-dimensional-MRCA, especially in the peripheral segments, and, thus, the diagnostic accuracy for the detection of CAD.
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8.
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, MP, Chezmar, JL, Rubin, DL, Weinreb, JC, Freeny, PC, Semelka, RC, Brown, JJ, Borello, JA, Lee, JK, Mattrey, R, et al
Journal of magnetic resonance imaging : JMRI. 2000;(1):186-97
Abstract
The short-term safety of mangafodipir trisodium (MnDPDP) injection was studied in 546 adults with known or suspected focal liver lesions. An initial contrast-enhanced computed tomography examination was followed by unenhanced magnetic resonance imaging (MRI), injection of MnDPDP (5 micromol/kg), and enhanced MRI. Adverse events were reported for 23% of the patients; most were mild to moderate in intensity, did not require treatment, and were not drug related. The most commonly reported adverse events were nausea (7%) and headache (4%). The incidence of serious adverse events was low (nine events in six patients) and not drug related. Injection-associated discomfort was reported for 69% of the patients, and the most commonly reported discomforts included heat (49%) and flushing (33%). Changes in laboratory values and vital signs were generally transient, were not clinically significant, and did not require treatment. There were no clinically significant short-term risks from exposure to MnDPDP.
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9.
Dynamic MR imaging of liver metastases with Gd-EOB-DTPA.
Stern, W, Schick, F, Kopp, AF, Reimer, P, Shamsi, K, Claussen, CD, Laniado, M
Acta radiologica (Stockholm, Sweden : 1987). 2000;(3):255-62
Abstract
PURPOSE To assess liver and lesion enhancements by dynamic MR imaging after bolus injection of the hepatobiliary contrast agent gadolinium ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gd-EOB-DTPA) in patients with liver metastases and to compare the effect of different doses. MATERIAL AND METHODS A randomized double-blinded trial with doses of 12.5, 25 and 50 micromol/kg Gd-EOB-DTPA was performed in 35 patients with liver metastases. Liver enhancement, tumor enhancement and liver lesion contrast-to-noise (C/N) ratios were calculated from breath-hold gradient echo images (100/5/80 degrees) recorded precontrast and at different times up to 10 min postcontrast. RESULTS Normal liver showed a characteristic enhancement pattern, with a rapid enhancement in the first 45 s postcontrast and a slight but significant further increase up to 600 s. The initial enhancement in the lesions was also pronounced, but the enhancement was slightly decreased after 240 s postcontrast. At dose levels of 12.5 and 25 micromol/kg Gd-EOB-DTPA, C/N ratios significantly increased compared to baseline from 90 to 600 s. Postcontrast C/N-values obtained using 50 micromol/kg Gd-EOB-DTPA were not significantly increased, except for the examinations 480 s postcontrast. CONCLUSION In liver metastases, C/N ratios obtained with doses of 12.5 and 25 micromol/kg Gd-EOB-DTPA were slightly superior to 50 micromol/kg Gd-EOB-DTPA. This finding is probably due to a more pronounced extracellular effect of the contrast medium at higher doses.