check_circleStudy Completed
Hepatic Neoplasms
Bayer Identifier:
90956
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Identification of hepatic lesions
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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
218Trial Dates
April 2001 - May 2003Phase
Phase 3Could I Receive a placebo
NoProducts
Resovist (Ferucarbotran, BAY86-4884)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Ospedale di Cattinara | Trieste, 34149, Italy |
Completed | Policlinico Universitario di Udine | Udine, 33100, Italy |
Completed | Spedali Civili di Brescia | Brescia, 25123, Italy |
Completed | Policlinico Careggi | Firenze, 50100, Italy |
Completed | Università G.D'Annunzio | Chieti, 66100, Italy |
Completed | Policlinico S.Orsola-Malpighi | Bologna, 40100, Italy |
Completed | Università La Sapienza | Roma, 00161, Italy |
Completed | Università di L'Aquila | L'Aquila, 67100, Italy |
Completed | Policlinico Universitario Giaccone | Palermo, Italy |
Completed | Istituto Europeo di Oncologia | Milano, Italy |
Completed | Ospedale Sant'Eugenio | Roma, 00144, Italy |
Completed | Policlinico Consorziale | Bari, 70124, Italy |
Completed | Ospedale S.G. Battista Le Molinette | Torino, 10154, Italy |
Completed | Ospedale San Paolo | Milano, 20142, Italy |
Completed | Policlinico S.Orsola-Malpighi | Bologna, 40100, Italy |
Completed | Ospedale Santa Chiara | Pisa, 56126, Italy |
Completed | Ospedale San Raffaele | Milano, 20132, Italy |
Completed | Policlinico Borgo Roma | Verona, 37134, Italy |
Completed | Università di Sassari | Sassari, 07100, Italy |
Completed | A.O.U. San Martino genova | Genova, 16132, Italy |
Primary Outcome
- 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.enhanced_encryptionNoneSafety Issue:
Secondary Outcome
- To assess the number, size , location and character of liver lesions.enhanced_encryptionNoneSafety Issue:
- To assess the diagnostic confidence of MRI and CT.enhanced_encryptionNoneSafety Issue:
- To assess the proportion of changed therapeutical decisions.enhanced_encryptionNoneSafety Issue:
- To assess sensitivity and specificity of MRI and CT.enhanced_encryptionNoneSafety Issue:
- To assess safety and tolerability of SH U 555 A administration.enhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Procedure/SurgeryTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1