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.
1. 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
The patient should be in a condition that allows subsequent treatment.
2. 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
3. Sign and date fully informed consent prior to entry into the study.
- Patients under 18 years of age.
- Patients weighing less than 35 kg.
- Patients who have received any investigational drug within the 30 days prior to
entering this study.
- Patients who have previously entered this study or any other study performed with SH
U 555 A.
- Women who are pregnant or who are of childbearing potential and have not had a
negative urine pregnancy test immediately prior to the administration of SH U 555 A.
The urine pregnancy test should be performed in accordance with the manufacturer's
- Lactating women.
- Patients who have any contraindication to MRI examination.
- Patients who have received any contrast material in the 24 hours prior to SH U 555 A
injection, or who are scheduled to receive any contrast material within 24 hours
afterwards. (In the case of any liver specific agent (e.g. MnDPDP, SPIOs, Gd-BOPTA)
this will be extended to 14 days prior to the study).
- Patients who have received Lipiodol contrast material at any time in the past or are
scheduled to receive this during the study period.
- Patients who are clinically unstable and whose clinical course during the observation
period is unpredictable (e.g. due to previous surgery).
- Patients scheduled for liver biopsy within 24 hours, or who had a biopsy within the
24 hours prior to planned SH U 555 A injection.
- Patients who are scheduled for, or are likely to require, surgery within 24 hours
after SH U 555 A injection.
- Patients with a history of anaphylactoid or anaphylactic reaction to any allergen
including drugs and contrast agents.
- Patients with known hypersensitivity to any of the ingredients of SH U 555 A.
- Patients with already clear op-indication