Clinical trial NCT06257277: An Observational Study to Collect Information on the Safety of Gadolinium-Based Contrast Agents in Patients in India
Official title: Active Surveillance of the Safety of Gadolinium-based Contrast Agent(s) in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Enhancement in Magnetic Resonance Imaging
Keywords: MRI
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events reported after use of branded gadolinium-based contrast agent (GBCA).
timeFrame: Immediately post dose and at 6 (±2) weeks post dose
measure: Number for participants with adverse events after use of a branded GBCA
timeFrame: From injection of GBCAs up to 6 (±2) weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: India
facility: Many locations
Study officials:
References: