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Identification of Hepatic Lesions

Primary Purpose

Hepatic Neoplasms

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Resovist (BAY86-4884, SH U 555 A)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatic Neoplasms focused on measuring Known or suspected focal liver lesions detected by spiral CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
March 27, 2006
Last Updated
May 15, 2009
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00307866
Brief Title
Identification of Hepatic Lesions
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

5. Study Description

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.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Neoplasms
Keywords
Known or suspected focal liver lesions detected by spiral CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Resovist (BAY86-4884, SH U 555 A)
Intervention Description
Single bolus injection, followed by MRI
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess the number, size , location and character of liver lesions.
Title
To assess the diagnostic confidence of MRI and CT.
Title
To assess the proportion of changed therapeutical decisions.
Title
To assess sensitivity and specificity of MRI and CT.
Title
To assess safety and tolerability of SH U 555 A administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
City
Bologna
State/Province
BO
ZIP/Postal Code
40100
Country
Italy
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
City
Firenze
State/Province
FI
ZIP/Postal Code
50100
Country
Italy
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
City
Milano
State/Province
MI
ZIP/Postal Code
20142
Country
Italy
City
Milano
State/Province
MI
Country
Italy
City
Palermo
State/Province
PA
Country
Italy
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
City
Torino
State/Province
TO
ZIP/Postal Code
10154
Country
Italy
City
Trieste
State/Province
TS
ZIP/Postal Code
34149
Country
Italy
City
Verona
State/Province
VE
ZIP/Postal Code
37134
Country
Italy
City
Chieti
ZIP/Postal Code
66100
Country
Italy
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
City
Roma
ZIP/Postal Code
00144
Country
Italy
City
Roma
ZIP/Postal Code
00161
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy

12. IPD Sharing Statement

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Identification of Hepatic Lesions

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