An observational study in Contrast Enhancement in Magnetic Resonance Imaging, sponsored by Bayer. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by Bayer · Observational
This is an observational study in which data from patients undergoing enhanced MRI using gadolinium based agents (GBCAs) are collected and studied.
An MRI is a test that uses strong magnets and radio waves to make detailed pictures of the inside of the body. The contrast agents commonly used in MRI are gadolinium based contrast agents (GBCAs). GBCAs contain a "rare earth" element called gadolinium (Gd), which helps to increase the signal intensity and contrast in MRI.
GBCAs have been used worldwide for MRI scans. GBCAs are generally considered safe. In some cases, there have been reports of mild to moderate side effects. There have also been reports indicating that small traces of Gd might stay in the body for an extended period after scans. However, there is no clear evidence that this causes any serious or long term problems in patients with normal kidney function.
There are different brands of GBCAs such as Gadovist and Magnevist. Knowledge about the safety of Gadovist and Magnevist in the Indian population is limited.
This study aims to enhance the currently available information on GBCAs and gather more information on the safety of Gadovist and Magnevist in the Indian population during GBCA enhanced MRI procedures in routine practice.
To do this, researchers will collect the following information:
Patients will be asked to take part in the study only after confirming that they need a GBCA enhanced MRI, and the GBCA brand is already identified.
Data will be collected from February 2024 to September 2024. Healthcare professionals will collect safety data from selected sites which frequently conduct GBCA enhanced MRIs for patients who have not received GBCAs before.
Every patient scheduled for an MRI with contrast agents will be followed up at approximately 4 and 12 weeks after the GBCA enhanced MRI.
In this study, only safety data from routine practice are collected.
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.
All patients that require GBCA-enhanced MRI and are willing to participate in the active surveillance and agree to be contacted by phone after 6 (±2) weeks after the MR scan for brief interviews.
Exclusion Criteria:
Patients who are scheduled to undergo magnetic resonance imaging (MRI) with gadolinium-based contrast agent (GBCA) enhancement as per routine clinical practice.
Drug: GBCAs
GBCAs are given per routine clinical practice.
Number of adverse events reported after use of branded gadolinium-based contrast agent (GBCA).
Time frame: Immediately post dose and at 6 (±2) weeks post dose
Number for participants with adverse events after use of a branded GBCA
Time frame: From injection of GBCAs up to 6 (±2) weeks
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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