Multicenter trial: comparison of two different formulations and application systems of low-dose nasal midazolam for routine magnetic resonance imaging of claustrophobic patients.

PURPOSE: To prospectively assess and compare two formulations and methods of administration of low-dose nasal midazolam for the treatment of claustrophobic patients undergoing magnetic resonance imaging (MRI) as part of a multicenter Phase III trial. MATERIALS AND METHODS: In all, 108 consecutive adult claustrophobic patients were randomly assigned to one of two treatment groups (multidose group: MDG, unit-dose group: UDG). MDG encompassed 55 patients who received intranasally a 0.5% midazolam formulation into each nostril (total dose, 1.0 mg), whereas the 53 patients in UDG received a 1% midazolam formulation into only one nostril (total dose, 1.0 mg). This initial dose could be repeated once. Patient tolerance and anxiety were assessed using a questionnaire and a visual analog scale immediately before and after MRI. Image quality was evaluated using a five-point scale. RESULTS: In all, 53/55 MR examinations (96%) with MDG and 52/53 (98%) with UDG were completed successfully. The dose of 1 mg had to be repeated significantly less often in UDG compared to MDG (4/53, 8% vs. 13/55, 24%; P = 0.003). The image quality of all MR examinations was rated good to excellent, and slightly better in UDG (P = 0.045). CONCLUSION: Nasally applied low-dose midazolam is a patient-friendly solution to facilitate MRI of claustrophobic patients. The nasal spray of UDG is superior to that of MDG with a necessity of additional dosing.

Contrast-enhanced MR cholangiography with Gd-EOB-DTPA in patients with liver cirrhosis: visualization of the biliary ducts in comparison with patients with normal liver parenchyma.

The purpose of this study was to assess the quality of biliary duct visualization using Gd-EOB-DTPA-enhanced magnetic resonance cholangiography (EOB-MRC) in patients with liver cirrhosis. Forty adult patients with liver cirrhosis (cirrhosis group) and 20 adult individuals with normal liver parenchyma (control group) underwent EOB-MRC using T1-weighted GRE imaging up to 180 min after Gd-EOB-DTPA administration. Two observers assessed the visualization of each biliary structure and the overall anatomical visualization of the biliary tree. Child-Pugh, MELD score and laboratory findings were compared. The grade of visualization for each evaluated biliary structure was statistically different in the two groups (P = 0.004 to <0.001). The overall EOB-MRC quality was rated as sufficient for anatomical visualization of the biliary tree in all individuals of the control group 20 min after Gd-EOB-DTPA application, but in only 16/40 patients (40%) of the cirrhosis group within 30 min after application. Analysis of the ROC curves revealed that the cut-off values, for non-sufficient visualization of the biliary tree 20 min after Gd-EOB-DTPA application, were MELD scores > or =11 and total serum bilirubin levels > or =30 micromol/l. Consecutively, EOB-MRC in patients with liver cirrhosis resulted in a decreased or even non-visualization of the biliary tree in a substantial percentage of patients.

Clinical proof-of-concept trial to assess the therapeutic effect of sirolimus in patients with autosomal dominant polycystic kidney disease: SUISSE ADPKD study.

BACKGROUND: Currently there is no effective treatment available to retard cyst growth and to prevent the progression to end-stage renal failure in patients with autosomal dominant polycystic kidney disease (ADPKD). Evidence has recently been obtained from animal experiments that activation of the mammalian target of rapamycin (mTOR) signaling pathway plays a crucial role in cyst growth and renal volume expansion, and that the inhibition of mTOR with rapamycin (sirolimus) markedly slows cyst development and renal functional deterioration. Based on these promising results in animals we have designed and initiated the first randomized controlled trial (RCT) to examine the effectiveness, safety and tolerability of sirolimus to retard disease progression in ADPKD. METHOD/DESIGN: This single center, randomised controlled, open label trial assesses the therapeutic effect, safety and tolerability of the mTOR inhibitor sirolimus (Rapamune) in patients with autosomal dominant polycystic kidney disease and preserved renal function. The primary outcome will be the inhibition of kidney volume growth measured by magnetic resonance imaging (MRI) volumetry. Secondary outcome parameters will be preservation of renal function, safety and tolerability of sirolimus. DISCUSSION: The results from this proof-of-concept RCT will for the first time show whether treatment with sirolimus effectively retards cyst growth in patients with ADPKD.

Low-dose intranasal versus oral midazolam for routine body MRI of claustrophobic patients.

The purpose of this study was to assess prospectively the potential of low-dose intranasal midazolam compared to oral midazolam in claustrophobic patients undergoing routine body magnetic resonance imaging (MRI). Seventy-two adult claustrophobic patients referred for body MRI were randomly assigned to one of two treatment groups (TG1 and TG2). The 36 patients of TG1 received 7.5 mg midazolam orally 15 min before MRI, whereas the 36 patients of TG2 received one (or, if necessary, two) pumps of a midazolam nasal spray into each nostril immediately prior to MRI (in total, 1 or 2 mg). Patients' tolerance, anxiety and sedation were assessed using a questionnaire and a visual analogue scale immediately before and after MRI. Image quality was evaluated using a five-point-scale. In TG1, 18/36 MRI examinations (50%) had to be cancelled, the reduction of anxiety was insufficient in 12/18 remaining patients (67%). In TG2, 35/36 MRI examinations (97%) were completed successfully, without relevant adverse effects. MRI image quality was rated higher among patients of TG2 compared to TG1 (p<0.001). Low-dose intranasal midazolam is an effective and patient-friendly solution to overcome anxiety in claustrophobic patients in a broad spectrum of body MRI. Its anxiolytic effect is superior to that of the orally administrated form.

Burkitt's lymphoma with bilateral cavernous sinus and mediastinal involvement in a child.

We report a 12-year-old boy who presented with incomplete right ophthalmoplegia, exophthalmos and headache. Initial CT and MRI revealed a mass in the right cavernous sinus. During tumour work-up, CT identified additional tumour within the mediastinum. Biopsy of the mediastinal lesion identified Burkitt's lymphoma. We report on this case because radiologists and clinicians should be alerted to identify sites of primary Burkitt's lymphoma outside of the central nervous system if clinical symptoms indicate, or imaging shows, CNS lesions. Primary CNS involvement in Burkitt's lymphoma is rare.

Prevalence and size of meniscal cysts, ganglionic cysts, synovial cysts of the popliteal space, fluid-filled bursae, and other fluid collections in asymptomatic knees on MR imaging.

OBJECTIVE: The purposes of this study were to evaluate the prevalence and determine the size of meniscal cysts, ganglionic cysts, synovial cysts of the popliteal space, fluid-filled bursae, and other fluid collections on MR images of asymptomatic knees. MATERIALS AND METHODS: MR images of 102 asymptomatic knees were evaluated with regard to the prevalence of meniscal cysts, ganglionic cysts, synovial cysts of the popliteal space, fluid-filled bursae, and other fluid collections. The MR examinations were performed in patients (mean age, 42.8 years; age range, 18-73 years) with clinically suspected meniscal lesions in the contralateral knee. The craniocaudal, anteroposterior, and mediolateral diameters of detectable abnormal fluid collections were measured. RESULTS: Medial meniscal cysts (mean size [craniocaudal x anteroposterior x mediolateral], 9 x 6 x 13 mm) were found in four asymptomatic knees. Neither lateral meniscal cysts nor ganglionic cysts of the cruciate ligaments were identified. Twenty-six synovial cysts of the popliteal space (Baker's cyst)-consisting of 11 gastrocnemius portions (mean size, 19 x 8 x 10 mm) and 15 semimembranosus portions (mean size, 20 x 7 x 9 mm)-were found in 19 knees. Twenty-four (92%) of these cysts had a maximal diameter of 30 mm or less. Fluid-filled bursae were found in 49 knees. The deep infrapatellar bursa was most commonly involved (42 knees; mean size, 6 x 3 x 5 mm). Fluid-filled anserine bursae (mean size, 27 x 12 x 10 mm) were detected in five knees. CONCLUSION: Meniscal cysts may be present in asymptomatic knees, at least on the medial side. Synovial cysts of the popliteal space can be found in approximately one fifth of asymptomatic knees. Their maximal diameter is usually smaller than 30 mm.