Trial Condition(s):
Identification of hepatic lesions
90956
Not Available
Not Available
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.
- 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.
- 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 recommendations. - 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
Locations | Status | |
---|---|---|
Locations Ospedale di Cattinara Trieste, Italy, 34149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario di Udine Udine, Italy, 33100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Careggi Firenze, Italy, 50100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università G.D'Annunzio Chieti, Italy, 66100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico S.Orsola-Malpighi Bologna, Italy, 40100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università La Sapienza Roma, Italy, 00161 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di L'Aquila L'Aquila, Italy, 67100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Universitario Giaccone Palermo, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istituto Europeo di Oncologia Milano, Italy | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Sant'Eugenio Roma, Italy, 00144 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Consorziale Bari, Italy, 70124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale S.G. Battista Le Molinette Torino, Italy, 10154 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Paolo Milano, Italy, 20142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale Santa Chiara Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ospedale San Raffaele Milano, Italy, 20132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Policlinico Borgo Roma Verona, Italy, 37134 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università di Sassari Sassari, Italy, 07100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Martino genova Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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.
Trial Type:
Interventional
Intervention Type:
Procedure/Surgery
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1