An Observational Study to Collect Information on the Safety of Gadolinium-Based Contrast Agents in Patients in India

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:

* any possible medical problems occurring immediately after receiving GBCAs (Gadovist and Magnevist), and after 4 and 12 weeks of receiving GBCAs * frequency of reporting medical problems after the use of GBCAs (Gadovist and Magnevist)

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.

Completed

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Key information

Conditions

Contrast Enhancement in Magnetic Resonance Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

GBCA-naïve male/female patients of at least 18 years of age.
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

None.

Treatment and study plan

GBCAs

Drug

GBCAs are given per routine clinical practice.

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Active Surveillance of the Safety of Gadolinium-based Contrast Agent(s) in India

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 13, 2024
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed