Hepatic NeoplasmsPhase 3NCT00307866
Identification of Hepatic Lesions
A Phase 3 study testing Resovist (BAY86-4884, SH U 555 A) in people with Hepatic Neoplasms, run by Bayer at 19 sites in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Neoplasms
- What is being tested?
- Resovist (BAY86-4884, SH U 555 A)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 19 sitesItaly
- Study dates
- Apr 2001to May 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
Study site
Bari, BA, 70124
Study site
Bologna, BO, 40100
Study site
Brescia, BS, 25123
Study site
Chieti, 66100
Study site
Florence, FI, 50100
Study site
Genova, GE, 16132
Study site
L’Aquila, 67100
Study site
Milan, MI, 20132
Study site
Milan, MI, 20142
Study site
Milan, MI
Study site
Palermo, PA
Study site
Pisa, PI, 56126
Study site
Roma, Roma, 00144
Study site
Roma, 00161
Study site
Sassari, SS, 07100
Study site
Torino, TO, 10154
Study site
Trieste, TS, 34149
Study site
Udine, 33100
Study site
Verona, VE, 37134
About this study
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.
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.
- Conditions
- Hepatic Neoplasms
- Being tested
- Resovist (BAY86-4884, SH U 555 A)
- Keywords
- Known or suspected focal liver lesions detected by spiral CT
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resovist (BAY86-4884, SH U 555 A)Procedure or surgery
Single bolus injection, followed by MRI
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Procedure: Resovist (BAY86-4884, SH U 555 A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2006 (estimated)
- Study startApr 2001
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307866
- Sponsor's protocol ID
- 90956
- Other IDs
- 304668
- Status last verified
- May 2009
- First submitted
- 27 Mar 2006
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00307866
- Acronym / sponsor ID
- 90956
- Conditions
- Hepatic Neoplasms
- Keywords
- Known or suspected focal liver lesions detected by spiral CT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- May 2003 (actual)
- First posted
- 28 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: Resovist (BAY86-4884, SH U 555 A) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resovist (BAY86-4884, SH U 555 A)Single bolus injection, followed by MRI | Procedure or surgery | Arm 1 |
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.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resovist (BAY86-4884, SH U 555 A) in people with Hepatic Neoplasms, run by Bayer at 19 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2009.