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| ID | Type | Description | Link |
|---|---|---|---|
| 304668 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resovist (BAY86-4884, SH U 555 A) | Procedure | Single bolus injection, followed by MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 more than five liver lesions on type visualized on CT.
The patient should be in a condition that allows subsequent treatment.
Be willing and able to continue study participation following administration of SH U 555 A to ensure completion of all procedures and observations required by the trial protocol.
Sign and date fully informed consent prior to entry into the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bari | BA | 70124 | Italy | |||
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C065507 | ferumoxides |
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| To assess sensitivity and specificity of MRI and CT. |
| To assess safety and tolerability of SH U 555 A administration. |
| Bologna |
| BO |
| 40100 |
| Italy |
| Brescia | BS | 25123 | Italy |
| Florence | FI | 50100 | Italy |
| Genova | GE | 16132 | Italy |
| Milan | MI | 20132 | Italy |
| Milan | MI | 20142 | Italy |
| Milan | MI | Italy |
| Palermo | PA | Italy |
| Pisa | PI | 56126 | Italy |
| Roma | Roma | 00144 | Italy |
| Sassari | SS | 07100 | Italy |
| Torino | TO | 10154 | Italy |
| Trieste | TS | 34149 | Italy |
| Verona | VE | 37134 | Italy |
| Chieti | 66100 | Italy |
| L’Aquila | 67100 | Italy |
| Roma | 00161 | Italy |
| Udine | 33100 | Italy |
| D008107 |
| Liver Diseases |