Identification of Hepatic Lesions

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00307866
First received: March 27, 2006
Last updated: May 15, 2009
Last verified: May 2009
  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.


Condition Intervention Phase
Hepatic Neoplasms
Procedure: Resovist (BAY86-4884, SH U 555 A)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

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.

Enrollment: 218
Study Start Date: April 2001
Study Completion Date: May 2003
Arms Assigned Interventions
Experimental: Arm 1 Procedure: Resovist (BAY86-4884, SH U 555 A)
Single bolus injection, followed by MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. 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.
  3. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00307866

Locations
Italy
Bari, BA, Italy, 70124
Bologna, BO, Italy, 40100
Brescia, BS, Italy, 25123
Firenze, FI, Italy, 50100
Genova, GE, Italy, 16132
Milano, MI, Italy, 20132
Milano, MI, Italy, 20142
Milano, MI, Italy
Palermo, PA, Italy
Pisa, PI, Italy, 56126
Sassari, SS, Italy, 07100
Torino, TO, Italy, 10154
Trieste, TS, Italy, 34149
Verona, VE, Italy, 37134
Chieti, Italy, 66100
L'Aquila, Italy, 67100
Roma, Italy, 00161
Roma, Italy, 00144
Udine, Italy, 33100
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00307866     History of Changes
Other Study ID Numbers: 90956, 304668
Study First Received: March 27, 2006
Last Updated: May 15, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Bayer:
Known or suspected focal liver lesions detected by spiral CT

Additional relevant MeSH terms:
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 15, 2014