Identification of Hepatic Lesions
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.
2 other identifiers
interventional
218
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2001
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 27, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedMay 18, 2009
May 1, 2009
March 27, 2006
May 15, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (5)
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.
To assess sensitivity and specificity of MRI and CT.
To assess safety and tolerability of SH U 555 A administration.
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (19)
Unknown Facility
Bari, BA, 70124, Italy
Unknown Facility
Bologna, BO, 40100, Italy
Unknown Facility
Brescia, BS, 25123, Italy
Unknown Facility
Florence, FI, 50100, Italy
Unknown Facility
Genova, GE, 16132, Italy
Unknown Facility
Milan, MI, 20132, Italy
Unknown Facility
Milan, MI, 20142, Italy
Unknown Facility
Milan, MI, Italy
Unknown Facility
Palermo, PA, Italy
Unknown Facility
Pisa, PI, 56126, Italy
Unknown Facility
Roma, Roma, 00144, Italy
Unknown Facility
Sassari, SS, 07100, Italy
Unknown Facility
Torino, TO, 10154, Italy
Unknown Facility
Trieste, TS, 34149, Italy
Unknown Facility
Verona, VE, 37134, Italy
Unknown Facility
Chieti, 66100, Italy
Unknown Facility
L’Aquila, 67100, Italy
Unknown Facility
Roma, 00161, Italy
Unknown Facility
Udine, 33100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2006
First Posted
March 28, 2006
Study Start
April 1, 2001
Study Completion
May 1, 2003
Last Updated
May 18, 2009
Record last verified: 2009-05