Identification of Hepatic Lesions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00307866|
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : May 18, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hepatic Neoplasms||Procedure: Resovist (BAY86-4884, SH U 555 A)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Completion Date :||May 2003|
|Experimental: Arm 1||
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307866
|Bari, BA, Italy, 70124|
|Bologna, BO, Italy, 40100|
|Brescia, BS, Italy, 25123|
|Firenze, FI, Italy, 50100|
|Genova, GE, Italy, 16132|
|Milano, MI, Italy, 20132|
|Milano, MI, Italy, 20142|
|Milano, MI, Italy|
|Palermo, PA, Italy|
|Pisa, PI, Italy, 56126|
|Sassari, SS, Italy, 07100|
|Torino, TO, Italy, 10154|
|Trieste, TS, Italy, 34149|
|Verona, VE, Italy, 37134|
|Chieti, Italy, 66100|
|L'Aquila, Italy, 67100|
|Roma, Italy, 00144|
|Roma, Italy, 00161|
|Udine, Italy, 33100|
|Study Director:||Bayer Study Director||Bayer|