Clinical safety and diagnostic value of the gadolinium chelate gadoterate meglumine (Gd-DOTA).

OBJECTIVE: The purpose of this study was to assess the diagnostic value and safety of the contrast agent gadoterate meglumine (Gd-DOTA, DOTAREM, Guerbet, Roissy CdG Cedex, France) in the setting of a postmarketing surveillance study. MATERIALS AND METHODS: Between January 2004 and October 2005, radiologists in 61 radiologic institutions were asked to document the routine use of Gd-DOTA in a questionnaire. In addition to assessing the image quality and diagnostic value of the contrast-enhanced magnetic resonance imaging scans, we statistically evaluated and analyzed demographic and safety data. RESULTS: A total of 24,308 patients were intravenously injected with Gd-DOTA for various diagnostic examinations. The examination allowed for establishing a diagnosis in >99% of cases and image quality was rated as "excellent" or "good" in 97.5% of all cases. Adverse events were noted in only 0.4% of the examinations and were mostly rated as minor, such as feeling of warmth or taste alteration. There was one serious adverse event, albeit with complete recovery. CONCLUSION: This postmarketing surveillance study suggests diagnostic efficacy and a favorable clinical safety profile of Gd-DOTA in clinical practice.

Comparison of the Detection Rate of Simulated Microcalcifications in Full-Field Digital Mammography, Digital Breast Tomosynthesis, and Synthetically Reconstructed 2-Dimensional Images Performed With 2 Different Digital X-ray Mammography Systems.

OBJECTIVE: The aim of this study was to compare the microcalcification detectability in an anthropomorphic phantom model regarding number, size, and shape in full-field digital mammography (FFDM), synthetically reconstructed 2-dimensional (Synthetic-2D) images, and digital breast tomosynthesis (DBT) performed with 2 different x-ray mammography systems. MATERIALS AND METHODS: Simulated microcalcifications of different numbers (0 to >39), sizes (diameter, 100-800 µm), and shapes (round vs heterogeneous) were scattered by random distribution on 50 film phantoms each divided in 4 quadrants. The FFDM and DBT x-rays were taken from each of these 50 films with both x-ray mammography systems (SenoClaire; GE Healthcare, Selenia Dimensions, Hologic) using an anthropomorphic scattering body and automatic exposure control. The resulting exposure factors were similar to a clinical setting. The synthetically reconstructed 2D images were generated automatically on both systems. All FFDM, Synthetic-2D, and DBT images were interpreted in randomized order and independently of each other by 6 radiologists using a structured questionnaire. RESULTS: The number categories of simulated microcalcifications were correctly evaluated in 55.3% of instances (quadrant by reader) in FFDM, 50.9% in the Synthetic-2D views, and 59.5% in DBT, summarized for 200 quadrants per reader for each Device A and B, respectively. Full-field digital mammography was superior to Synthetic-2D (mean difference, 4%; 95% confidence interval [CI], 2%-7%; P < 0.001), and DBT was superior to both FFDM (mean difference, 4%; 95% CI, 2%-7%; P = 0.002) and Synthetic-2D (mean difference, 9%; 95% CI, 6%-11%; P < 0.001). This trend was consistent in all subgroup analyses. The number of the smallest microcalcifications (100-399 µm) was correctly evaluated in 25.2% of the FFDM, in 14.2% for Synthetic-2D, and in 28.3% of the DBT images. Underestimations of the number of simulated microcalcifications were more common than overestimations. Regarding the size categories of simulated microcalcifications, the rates of correct assessments were in 45.4% of instances in FFDM, 39.9% in the Synthetic-2D views, and 43.6% in DBT, summarized for 200 quadrants per reader and both imaging devices. CONCLUSIONS: In the presented in vitro environment using an anthropomorphic phantom model, standard full-field digital x-ray mammography was superior to synthetically reconstructed 2-dimensional images in the detection of simulated microcalcifications. In view of these results, it is questionable whether Synthetic-2D images can replace FFDM in clinical examinations at the present time. Further investigations are needed to assess the clinical impact of the in vitro results.

Magnetic forces on orthodontic wires in high field magnetic resonance imaging (MRI) at 3 tesla.

BACKGROUND: In a previous investigation we reported on magnetic forces in the static magnetic field of a 1.5 Tesla MRI system. The aim of the present investigation was to assess forces on orthodontic wires in a high field strength MRI system at 3 Tesla. MATERIALS AND METHODS: Thirty-two different orthodontic wires (21 archwires, eight ligature wires and three retainer wires) were investigated in a 3 Tesla high field strength MRI system (Intera, Philips Medical Systems, Best, The Netherlands). Translational forces were measured by the deflection angle test (ASTM F2052-02), and rotational forces assessed on a 5-point qualitative scale. RESULTS AND CONCLUSION: Translational forces ranged between 43.5 mN and 136.1 mN for retainer wires and between 0.6 mN (Noninium) and 208.4 mN (Orthos Stainless Steel) for steel archwires. Translational forces were up to 53.8 times as high as gravitational forces for retainer wires and up to 54.5 times as high for steel archwires, associated with marked rotational forces for the most part. Archwires manufactured from nickel-titanium, titanium-molybdenum and cobalt-chromium and different ligature wires showed no or negligible forces in the magnetic field. Carefully ligated wires should not present a risk due to translational and rotational forces in the high field MRI system at 3 Tesla.

Magnetic field interactions of orthodontic wires during magnetic resonance imaging (MRI) at 1.5 Tesla.

BACKGROUND: Orthodontic appliances pose a potential risk during magnetic resonance imaging (MRI) due to forces on metallic objects within the static magnetic field of MRI systems. The aim of the present investigation was to measure forces on orthodontic wires caused by the static magnetic field of a 1.5-Tesla MRI system, and to assess the safety hazards associated with these forces. MATERIALS AND METHODS: Thirty-two different orthodontic wires (21 arch wires, eight ligature wires and three retainer wires) were investigated in a 1.5-Tesla MRI system (Magnetom Symphony, Siemens Medical Solutions, Erlangen, Germany). The translational forces were measured using the deflection angle test (ASTM F2052-02); rotational forces were assessed on a 5-point qualitative scale. RESULTS AND CONCLUSION: All retainer wires and the steel arch wires (the Noninium arch wire being the exception) were subjected to considerable rotational and translational forces within the MRI system's magnetic field. Translational forces were from 9.1- to 27.6-times as high as gravitational forces on these objects. Steel ligature wires and arch wires made of cobalt chromium, titanium molybdenum, nickel-titanium, and brass alloys showed no or negligible forces within the magnetic field. The translational and rotational forces within the MRI magnetic field should pose no risk to carefully-ligated arch wires. Steel retainer wire bonds should be checked to ensure secure attachment prior to an MRI investigation.

Radiofrequency-induced heating near fixed orthodontic appliances in high field MRI systems at 3.0 Tesla.

OBJECTIVE: To assess radiofrequency (RF)-induced heating of fixed orthodontic appliances during acquisition of three different sequences in magnetic resonance imaging (MRI) at 3 Tesla. MATERIALS AND METHODS: Ten commonly used fixed orthodontic appliances were investigated utilizing a phantom head and simulating the in vivo intraoral situation. A 3 Tesla MRI system (Intera, Philips Medical Systems, Best, The Netherlands) was used to acquire T1w spin-echo (T1 SE), T1w turbo spin-echo (T1 TSE) and T1w gradient-echo (T1 GRE) sequences in axial orientation. Continuous temperature measurement was performed with a dedicated four channel fluoroptic thermometry system. For each orthodontic appliance temperature probes were placed at three predefined sites in order to perform temperature measurements during MR imaging. The fourth temperature probe was fixed to the neck of the phantom head and served as the reference. Mean temperature alterations were determined for all appliances. RESULTS: Temperature elevations ranged from -0.3 degrees C to 0.2 degrees C and were negligible for all orthodontic appliances investigated. There was no difference in mean temperature alteration for any of the three imaging sequences. CONCLUSION: Based on the data of our experimental study the radiofrequency-induced heating of orthodontic brackets during high field MRI at 3 Tesla can be categorized as negligibly low. Even the clinical routine examination of the head at 3 Tesla using high-energetic pulse sequences can be applied without hesitation in patients with fixed orthodontic appliances.

Value of multiplanar reformations (MPR) in multidetector CT (MDCT) of acute vertebral fractures: do we still have to read the transverse images?

OBJECTIVE: To determine the value of multiplanar reformations (MPRs) in multidetector computed tomography (MDCT) diagnosis of acute vertebral fractures and to assess the necessity to read the whole set of transverse images. METHODS: Retrospectively, 56 MDCT of 55 patients with acute vertebral fractures were included. The images were analyzed by two radiologists in a consensus procedure. First, the diagnosis was made exclusively from sagittal and coronal MPRs; secondly, the transverse images were analyzed with knowledge of the MPRs. Diagnostic accuracy is given as percentage. Image amounts were compared using the Wilcoxon test. RESULTS: In 244 vertebral bodies, all 70 fractured vertebrae were diagnosed on reviewing MPRs only. There were no false positive cases. In 2/70 fractures, the anatomically exact diagnosis was complemented by reading the transverse images. Forty-two of 43 unstable fractures were diagnosed correctly on MPRs only. With preference of MPR reading, the total number of images to be analyzed could be reduced significantly (P < 0.01). CONCLUSION: Reading of MPRs alone is a feasible approach for correct assessment of vertebral fractures and classifying them into stable/unstable, if MPRs are done properly. Transverse images must be analyzed in complex fractures or uncertain findings.

Evaluation of the deep venous system in patients with suspected pulmonary embolism with multi-detector CT: a prospective study in comparison to Doppler sonography.

OBJECTIVE: This prospective study was done to evaluate the ability of indirect multidetector row CT venography (CTV) in detecting deep venous thrombosis of the pelvis and the thighs in comparison with Doppler sonography in patients with suspected pulmonary embolism (PE). METHODS: Forty-one patients with suspected PE were included, and CTV (collimation 4 x 2.5 mm, table feed 12.5 mm, 120 kV, eff. mAs 165) from the iliac crest to the knees was done after CT angiography (CTA) of the pulmonary arteries. Doppler sonography was performed within 24 hours. Applied radiation doses were estimated using the PC program WinDose. RESULTS: PE was diagnosed in 20 patients with additional DVT in 11 patients. The CTV has a sensitivity of 100%, specificity of 96.6%, a positive and negative predictive value of 91.7% and 100%, respectively. The median cumulative effective dose for CTV was 8.26 mSv with a gonadal dose of 3.87 mSv. Changing the CTV protocol to a collimation of 4 x 5 mm with a 25 mm table feed could reduce the dose by approximately 11% (p < 0.05) to 7.25 mSv and 3.35 mSv, respectively. CONCLUSION: CTV is a safe and quick diagnostic tool for detecting DVT in patients with suspected PE. Due to the relevant increase in radiation dose, the indication has to be considered very carefully.