- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874640
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)
To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application.
Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Many Locations, Germany
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist
Exclusion Criteria:
- No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
|
Patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium gadobutrol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Profile
Time Frame: At day of application
|
At day of application
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dosing of Gadovist in different indications
Time Frame: At time of application
|
At time of application
|
Adverse Events
Time Frame: Throughout and after application
|
Throughout and after application
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14317
- GV0810DE (Other Identifier: Company internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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