Identification of Hepatic Lesions
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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.|
- 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.
|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
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.
|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, 00161|
|Roma, Italy, 00144|
|Udine, Italy, 33100|
|Study Director:||Bayer Study Director||Bayer|