A Post Marketing Surveillance study of gadodiamide

Active, not recruiting

Brief Summary: | |

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|This is a single-arm, multi-center post-marketing surveillance study to evaluate the safety of gadodiamide in Gadolinium Based Contrast Agent (GBCA)-naÃ¯ve male/female patients of at least 18 years of age.

Three sites in India that frequently use Omniscan (i.e., Omniscan is on the formulary at the sentinel site and available for routine clinical use) and that have access to eligible patients will be selected. Up to 150 patients will be enrolled. Recruitment of patients will be open at a site for approximately 6 months or until 50 patients are included, whichever is shorter.

Healthcare professionals (HCPs) at each site will be trained on gadodiamide safety and applicable pharmacovigilance requirements. Patients will be informed about the active surveillance by site HCPs, consent will be documented. A questionnaire will be used for the collection of safety information.

All patients scheduled for contrast-enhanced MR imaging will be asked for permission to be contacted 6 (Â±2) weeks after the gadodiamide-enhanced imaging. Patients will be asked by an HCP (site personnel) about adverse experiences after gadodiamide administration.

Patients will be invited to participate only after the decision to gadodiamide-enhanced MRI has been made.

Recruitment & Eligibility

Inclusion Criteria

1.GBCA-naÃ¯ve male/female patients of at least 18 years of age.
2.Patients willing to participate in the active surveillance and agree to be contacted by phone after 6 (Â±2) weeks after the MR scan for brief interviews.

Exclusion Criteria

1.Patients known to have hypersensitivity to Omniscan or its constituents.
2.Patients with chronic, severe kidney disease (GFR<30ml/min/1.73m2), or acute kidney injury.

Primary Outcome Measures

Name	Time	Method
1. To detect all prospective adverse events immediately post dose and 6 (Â±2) weeks after administration of Omniscan.	Immediately post dose and 6 (Â±2) weeks after injection of Omniscan.
2. To estimate the reporting rate of adverse events after use of Omniscan.	Immediately post dose and 6 (Â±2) weeks after injection of Omniscan.
The parameters will be AEs segregation by MedDRA system organ classes and MedDRA preferred terms, by case and event seriousness, by causal relationship by latency (i.e., interval between injection of Omniscan and onset of AE), by duration and by outcome. Descriptive statistics will be done.	Immediately post dose and 6 (Â±2) weeks after injection of Omniscan.

Secondary Outcome Measures

Name	Time	Method

Locations (1): Mahajan Imaging
🇮🇳
Delhi, DELHI, India
Mahajan Imaging
🇮🇳Delhi, DELHI, India
Dr Nafisa Shakir Batta
Principal investigator
011-26170905
nafisa.shakir@gmail.com
Dr Pratibha S Shad
Principal investigator
011-43060599
pratibha.shrestha@gmail.com
Dr Pravin Vaze
Principal investigator
011-30611721
drpravinvaze@mahajanimaging.com