do_not_disturb_altRecruitment Complete

Contrast enhancement in magnetic resonance imaging

Bayer Identifier:

22584

ClinicalTrials.gov Identifier:

NCT06257277

EudraCT Number:

Not Available

EU CT Number:

Not Available
An Observational Study to Collect Information on the Safety of Gadolinium-Based Contrast Agents in Patients in India

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - None.

Trial summary

Enrollment Goal
150
Trial Dates
July 2024 - April 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
N/A
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many locationsMany locations, India

Primary Outcome

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

Trial design

Active surveillance of the safety of Gadolinium-based contrast agent(s) in India
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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