Neoplastic CNS LesionsPhase 4NCT00764387
Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions.
A Phase 4 study testing Gadovist® (Gadobutrol, BAY86-4875) and Dotarem in people with Neoplastic CNS Lesions, run by Bayer at 12 sites in Italy.
Trial summary
Study to compare of two contrast agents in imaging brain lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic CNS Lesions
- What is being tested?
- Gadovist® (Gadobutrol, BAY86-4875) and Dotarem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 12 sitesItaly
- Study dates
- Mar 2008to May 2009
- Phase
- Phase 4
- 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
- Known neoplastic CNS lesions
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
Study site
Andria, Bari, 70031
Study site
Catania, 95126
Study site
Chieti, 66013
Study site
Messina, 98122
Study site
Milan, 20132
Study site
Naples, 80131
Study site
Novara, 28100
Study site
Roma, 00133
Study site
Roma, 00168
Study site
Siena, 53100
Study site
Trieste, 34149
Study site
Verona, 37136
About this study
Official title: Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.
Study to compare of two contrast agents in imaging brain lesions.
- Conditions
- Neoplastic CNS Lesions
- Being tested
- Gadovist® (Gadobutrol, BAY86-4875), Dotarem
- Keywords
- Neoplastic CNS lesions, Contrast enhanced MRI, Comparison
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadovist® (Gadobutrol, BAY86-4875)Drug
0,1 mmol/kg of body weight in the vein, single administration
DotaremDrug
0,1 mmol/kg of body weight in the vein, single administration
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Gadovist® (Gadobutrol, BAY86-4875) |
| Arm 2 | Active comparator | Not described Receives: Drug: Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
Measured: October 2007 to November 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic CNS LesionsStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764387
- Sponsor's protocol ID
- 91780
- Other IDs
- 2007-005693-31, 312021
- Status last verified
- Dec 2014
- First submitted
- 3 Jul 2008
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-enhanced MRI Examination of Cerebral Neoplastic Enhancing Lesions: Comparison of Diagnostic Efficacy of Gd-DOTA 0.5M and Gadobutrol 1.0 M at 0.1 mmol/kg Body Weight: Intraindividual Comparison Clinical Study.
- ClinicalTrials.gov ID
- NCT00764387
- Acronym / sponsor ID
- 91780
- Conditions
- Neoplastic CNS Lesions
- Keywords
- Neoplastic CNS lesions, Contrast enhanced MRI, Comparison
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Oct 2008 (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.
Study to compare of two contrast agents in imaging brain lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Gadovist® (Gadobutrol, BAY86-4875) |
| Arm 2 | Active comparator | Drug: Dotarem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Known neoplastic CNS lesions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Gadovist® (Gadobutrol, BAY86-4875)0,1 mmol/kg of body weight in the vein, single administration | Drug | Arm 1 |
| Dotarem0,1 mmol/kg of body weight in the vein, single administration | Drug | Arm 2 |
Primary outcome
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis.
Time frame: October 2007 to November 2008
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 5 Dec 2014.
- Click here and search for Bayer Product information provided by EMALink provided by the sponsor.
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadovist® (Gadobutrol, BAY86-4875) and Dotarem in people with Neoplastic CNS Lesions, run by Bayer at 12 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 1 inclusion and 0 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The primary analysis will be the comparison of the enhancements characteristics of Gadobutrol and Gd-TOTA on a lesion per lesion basis. (time frame: October 2007 to November 2008). 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 5 Dec 2014.