do_not_disturb_altRecruitment Complete
Contrast enhancement in magnetic resonance imaging
Bayer Identifier:
22584
ClinicalTrials.gov Identifier:
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
150Trial Dates
July 2024 - April 2025Phase
Phase 4Could I Receive a placebo
NoProducts
N/AAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Many locations | Many 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 GBCAdate_rangeTime Frame:From injection of GBCAs up to 6 (±2) weeks
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A