Post Marketing study to check safety of the MRI Contrast Dye.

Active Surveillance Study of the Safety of MultiHance® in India.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/06/054128

Enrollment

150

Registered

2023-06-20

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: B- Imaging

Interventions

Intervention1: MultiHance® (gadobenate dimeglumine) 0.5 M Solution for Injection.: Administer MultiHance® manually or with a Power Injector. MRI of the Liver: 0.1mL/Kg of the 0.5M Solution MRI of the

Eligibility

Inclusion criteria

Inclusion criteria: 1. Is the subject = 18 years of age? 2. Is the subject scheduled to undergo MRI with MultiHance® as standard of care? 3. Is the subject willing to provide written informed consent and comply with protocol requirements?

Exclusion criteria

Exclusion criteria: 1. Did the subject receive prior GBCA? 2. Was the subject already included in the study?

Design outcomes

Primary

Measure	Time frame
Prospective Assessment of adverse events (AEs)Timepoint: From the time the ICF is signed are collected during the post-MR examination observation period, up to 30 minutes, and during a telephone contact to the subject performed 6 weeks (± 2 weeks) post-MultiHance® administration	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactPravinkumar Pal

CLINICA Research Solutions LLP

drajay.m@Clinicaresearch.com02249705627

Outcome results

None listed

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