| CTRI Number |
CTRI/2023/05/053235 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Post Marketing Surveillance study of gadodiamide |
|
Scientific Title of Study
|
A single-arm, multicentre, Post-marketing observational follow up on patients who have been given Gadolinium for clinical scans to detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OMNI-PV-22/ ver1.0/ 03 APR 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harsh Mahajan |
| Designation |
Founder Director |
| Affiliation |
Mahajan Imaging Pvt Ltd |
| Address |
K-18, Hauz Khas Enclave
New Delhi
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
hm@mahajanimaging.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmeet Sahni |
| Designation |
Medical Affairs Lead- India & South Asia |
| Affiliation |
GE HealthCare Ltd |
| Address |
Building 7A, DLF Cyber City, Phase III,
Sector 25
Gurgaon
HARYANA
122022
India |
| Phone |
9717357441 |
| Fax |
|
| Email |
jasmeet.sahni@ge.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mugdha Chopra |
| Designation |
Co- Founder & Director |
| Affiliation |
AWINSA Life Sciences |
| Address |
Tower-Sb, fifth floor, Film City, Sector 16A
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9350171220 |
| Fax |
|
| Email |
mugdha.chopra@awinsals.com |
|
|
Source of Monetary or Material Support
|
| GE HealthCare Ltd,
Building 7A, DLF Cyber City, Phase III
Sector 25, Gurgaon,
Haryana- 122002, India
|
|
|
Primary Sponsor
|
| Name |
GE HealthCare Ltd |
| Address |
Building 7A, DLF Cyber City, Phase III
Sector 25,
Gurgaon, Haryana- 122002, India
|
| Type of Sponsor |
Other [Global Medical Technology Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nafisa Shakir Batta |
Mahajan Imaging |
Sports Injuries Centre,
Safdarjung Hospital
New Delhi
DELHI |
011-26170905
nafisa.shakir@gmail.com |
| Dr Pratibha S Shad |
Mahajan Imaging |
7-B, Upper Ground Floor, Main, Pusa Rd,
Rajinder Nagar
New Delhi
DELHI |
011-43060599
pratibha.shrestha@gmail.com |
| Dr Pravin Vaze |
Mahajan Imaging |
PSRI Multispeciality Hospital,
Phase II,
Sheikh Sarai
New Delhi
DELHI |
011-30611721
drpravinvaze@mahajanimaging.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Mahajan Imaging Ethics Committee |
Approved |
| Mahajan Imaging Ethics Committee |
Approved |
| Mahajan Imaging Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil
|
Nil |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.GBCA-naïve 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 (±2) weeks after the MR scan for brief interviews.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan.
2. To estimate the reporting rate of adverse events after use 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 (±2) weeks after injection of Omniscan. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| This is a single-arm, multi-center post-marketing surveillance study to evaluate the safety of gadodiamide in Gadolinium Based Contrast Agent (GBCA)-naïve 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 (±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. | |