Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:52 PM
Study NCT ID:
NCT02540967
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2015-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Use Investigation of Gadovist.
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Drug Use Investigation of Gadovist
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
Detailed Description:
This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: