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CompletedNCT00307866Updated May 18, 2009

Identification of Hepatic Lesions

A Phase 3 interventional study of Resovist (BAY86-4884, SH U 555 A) in Hepatic Neoplasms, sponsored by Bayer. Completed at 19 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-05-18.

Sponsored by Bayer · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
218
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatic Neoplasms

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Keywords

  • Known or suspected focal liver lesions detected by spiral CT
03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's enrollment of 218 is above the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
218 participants (actual)

Study arms

  • Experimental
    Arm 1

    Procedure: Resovist (BAY86-4884, SH U 555 A)

Interventions

  • ProcedureResovist (BAY86-4884, SH U 555 A)

    Single bolus injection, followed by MRI

06

What researchers measure

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

  1. To assess the number, size , location and character of liver lesions.

  2. To assess the diagnostic confidence of MRI and CT.

  3. To assess the proportion of changed therapeutical decisions.

  4. To assess sensitivity and specificity of MRI and CT.

  5. To assess safety and tolerability of SH U 555 A administration.

07

Study locations

19 sites
  • Bari, BA 70124, Italy
  • Bologna, BO 40100, Italy
  • Brescia, BS 25123, Italy
  • Firenze, FI 50100, Italy
  • Genova, GE 16132, Italy
  • Milano, MI 20132, Italy
  • Milano, MI 20142, Italy
  • Milano, MI, Italy
  • Palermo, PA, Italy
  • Pisa, PI 56126, Italy
  • Sassari, SS 07100, Italy
  • Torino, TO 10154, Italy
  • Trieste, TS 34149, Italy
  • Verona, VE 37134, Italy
  • Chieti, 66100, Italy
  • L'Aquila, 67100, Italy
  • Roma, 00144, Italy
  • Roma, 00161, Italy
  • Udine, 33100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00307866
Lead sponsor
Bayer
First posted
Mar 28, 2006
Start date
Apr 2001
Completion
May 2003
Last update
May 18, 2009

Study contacts

Bayer Study Director
study director · Bayer
View the source record on ClinicalTrials.gov ↗

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