Trial Condition(s):

Hepatic Neoplasms

Identification of hepatic lesions

Bayer Identifier:

90956

ClinicalTrials.gov Identifier:

NCT00307866

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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
- 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

Trial Summary

Enrollment Goal
218
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Resovist (Ferucarbotran, BAY86-4884)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Ospedale di Cattinara

Trieste, Italy, 34149

Status
Completed
 
Locations

Policlinico Universitario di Udine

Udine, Italy, 33100

Status
Completed
 
Locations

Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

Policlinico Careggi

Firenze, Italy, 50100

Status
Completed
 
Locations

Università G.D'Annunzio

Chieti, Italy, 66100

Status
Completed
 
Locations

Policlinico S.Orsola-Malpighi

Bologna, Italy, 40100

Status
Completed
 
Locations

Università La Sapienza

Roma, Italy, 00161

Status
Completed
 
Locations

Università di L'Aquila

L'Aquila, Italy, 67100

Status
Completed
 
Locations

Policlinico Universitario Giaccone

Palermo, Italy

Status
Completed
 
Locations

Istituto Europeo di Oncologia

Milano, Italy

Status
Completed
 
Locations

Ospedale Sant'Eugenio

Roma, Italy, 00144

Status
Completed
 
Locations

Policlinico Consorziale

Bari, Italy, 70124

Status
Completed
 
Locations

Ospedale S.G. Battista Le Molinette

Torino, Italy, 10154

Status
Completed
 
Locations

Ospedale San Paolo

Milano, Italy, 20142

Status
Completed
 
Locations

Ospedale Santa Chiara

Pisa, Italy, 56126

Status
Completed
 
Locations

Ospedale San Raffaele

Milano, Italy, 20132

Status
Completed
 
Locations

Policlinico Borgo Roma

Verona, Italy, 37134

Status
Completed
 
Locations

Università di Sassari

Sassari, Italy, 07100

Status
Completed
 
Locations

A.O.U. San Martino genova

Genova, Italy, 16132

Status
Completed
 

Trial Design