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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00307866 |
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.
Condition | Intervention | Phase |
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Hepatic Neoplasms |
Procedure: Resovist |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Multicenter, Phase III b Clinical Study to Evaluate the Effectiveness of Unenhanced and SH U 555A (Resovist) Enhanced MRI, Compared to Contrast-Enhanced Dual-Phase Spiral CT in Assessing the Correct Final Therapy-Deciding Diagnosis, in Patients With Primary or Secondary Hepatic Malignancies. |
Study Start Date: | April 2001 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
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 morethan five liver lesions on type visualized on CT.
The patient should be in a condition that allows subsequent treatment.
Exclusion Criteria:
Study ID Numbers: | 304668 |
Study First Received: | March 27, 2006 |
Last Updated: | April 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00307866 |
Health Authority: | Italy: Ministry of Health |
Known or suspected focal liver lesions detected by spiral CT |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Liver neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms |
Neoplasms Neoplasms by Site |