check_circleStudy Completed

Hepatic Neoplasms

Bayer Identifier:

90956

ClinicalTrials.gov Identifier:

NCT00307866

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

Both

Age

18 Years
  • - 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.
  • - 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
April 2001 - May 2003
Phase
Phase 3
Could I Receive a placebo
No
Products
Resovist (Ferucarbotran, BAY86-4884)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Ospedale di CattinaraTrieste, 34149, Italy
Completed
Policlinico Universitario di UdineUdine, 33100, Italy
Completed
Spedali Civili di BresciaBrescia, 25123, Italy
Completed
Policlinico CareggiFirenze, 50100, Italy
Completed
Università G.D'AnnunzioChieti, 66100, Italy
Completed
Policlinico S.Orsola-MalpighiBologna, 40100, Italy
Completed
Università La SapienzaRoma, 00161, Italy
Completed
Università di L'AquilaL'Aquila, 67100, Italy
Completed
Policlinico Universitario GiacconePalermo, Italy
Completed
Istituto Europeo di OncologiaMilano, Italy
Completed
Ospedale Sant'EugenioRoma, 00144, Italy
Completed
Policlinico ConsorzialeBari, 70124, Italy
Completed
Ospedale S.G. Battista Le MolinetteTorino, 10154, Italy
Completed
Ospedale San PaoloMilano, 20142, Italy
Completed
Policlinico S.Orsola-MalpighiBologna, 40100, Italy
Completed
Ospedale Santa ChiaraPisa, 56126, Italy
Completed
Ospedale San RaffaeleMilano, 20132, Italy
Completed
Policlinico Borgo RomaVerona, 37134, Italy
Completed
Università di SassariSassari, 07100, Italy
Completed
A.O.U. San Martino genovaGenova, 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.
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    Safety Issue:
    None

Secondary Outcome

  • To assess the number, size , location and character of liver lesions.
    enhanced_encryption
    Safety Issue:
    None
  • To assess the diagnostic confidence of MRI and CT.
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    Safety Issue:
    None
  • To assess the proportion of changed therapeutical decisions.
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    Safety Issue:
    None
  • To assess sensitivity and specificity of MRI and CT.
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    Safety Issue:
    None
  • To assess safety and tolerability of SH U 555 A administration.
    enhanced_encryption
    Safety Issue:
    None

Trial design

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.
Trial Type
Interventional
Intervention Type
Procedure/Surgery
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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