Meniere Disease

Imaging of Endolymphatic Hydrops at 7T MRI

Imaging Endolymphatic Hydrops at 7T MRI: Validation of Internal Inner Ear Structures on T2w Imaging as Markers of Endolymphatic Hydrops and a Comparison of Diagnostic Outcomes With 3T MRI

Confidence of visibility of selected inner ear structures at 3T and 7T on HR T2w and delayed post gad 3D IR (two observers)

Measurements of the size and location of selected inner ear structures at 3T and 7T on HRT2 and delayed post gad 3D IR (two observers)

Semi-quantitative grading of endolymphatic hydrops at 3T and 7T on HRT2 and delayed post gad 3D IR

King's College Hospital NHS Trust

King's College London

Guy's and St Thomas' NHS Foundation Trust

Patients with a clinical concern for pulmonary embolus but not able to receive iodinated contrast will be enrolled. Ferumoxytol will be administered as a contrast agent in coordination with magnetic resonance angiography to identify patency of the cardiopulmonary vasculature.

Pulmonary Embolism

ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus

Ferumoxytol

Brigham and Women's Hospital

Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Detection of pulmonary embolus with ferumoxytol-enhanced magnetic resonance angiography

Data will be offered in publication supplemental material

Andrew Michael Siedlecki

Instructor in Medicine

Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient

Gadoxetic Acid Disodium (Primovist, BAY86-4873)

Sex: Female, Male

Characterization of first liver lesion type of referral diagnosis

Characterization of second liver lesion type of referral diagnosis

Characterization of third liver lesion type of referral diagnosis

Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points

The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.

Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points

Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.

Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points

Overall Study

Therapeutic Area Head

Known or Suspected Focal Liver Lesions

Efficacy and Safety of Primovist in Chinese Patients

A Multicenter, Open-label Phase III Study of the Efficacy and Safety of Primovist as a Contrast Agent for Enhanced MR Imaging of Focal Liver Lesions in Chinese Patients

nephrogenic fibrosing dermopathy/ödem

Imaging of Endolymphatic Hydrops at 7T MRI

Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography

Efficacy and Safety of Primovist in Chinese Patients

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