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To conduct survey of safety of Gadolinium-based substance used to improve the visibility of internal body structures in Magnetic Resonance Imaging (MRI) in India

Active surveillance of the safety of Gadolinium-based contrast agent(s) in India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/066403
Enrollment
150
Registered
2024-04-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R948- Abnormal results of function studies of other organs and systems

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Bayer Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. GBCA-naïve male or female patients of at least 18 years of age 2. 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

Exclusion criteria: There is no specific exclusion criteria.

Design outcomes

Secondary

MeasureTime frame
To estimate the reporting rate of adverse events after use of a branded GBCA.Timepoint: 6 weeks—

Primary

MeasureTime frame
To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of branded GBCA.Timepoint: 6 weeks—

Countries

India

Contacts

Public ContactDr Vaibhav Hublikar

Bayer Pharmaceuticals Private Limited

vaibhav.hublikar@bayer.com7506210386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026