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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Contrast Enhancement in Magnetic Resonance Imaging
• Intervention / Treatment: Drug: GBCAs

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients require GBCA-enhanced MRI; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of adverse events reported after use of branded gadolinium-based contrast agent (GBCA).	Immediately post dose and at 6 (±2) weeks post dose
Number for participants with adverse events after use of a branded GBCA	From injection of GBCAs up to 6 (±2) weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study record dates

Study Major Dates

• Study Start (Estimated): April 24, 2024
• Primary Completion (Estimated): November 18, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: MRI
• Other Study ID Numbers: 22584

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No