A Phase 3 interventional study of Resovist (BAY86-4884, SH U 555 A) in Hepatic Neoplasms, sponsored by Bayer. Completed at 19 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-18.
Sponsored by Bayer · Phase 3, Interventional, and Diagnostic
Patients with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 218 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Present with suspicion of primary or secondary hepatic malignancy in whom a radiological examination is needed in order to decide on the most appropriate treatment. There should not be more than five liver lesions on type visualized on CT.
The patient should be in a condition that allows subsequent treatment.
Exclusion Criteria:
Procedure: Resovist (BAY86-4884, SH U 555 A)
Single bolus injection, followed by MRI
To assess the proportion of correct final, therapy deciding diagnosis based on unenhanced plus SH U 555 A enhanced MR imaging compared to contrast-enhanced dual-phase spiral CT.
To assess the number, size , location and character of liver lesions.
To assess the diagnostic confidence of MRI and CT.
To assess the proportion of changed therapeutical decisions.
To assess sensitivity and specificity of MRI and CT.
To assess safety and tolerability of SH U 555 A administration.
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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