| CTRI Number |
CTRI/2024/10/075817 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the safety of Dotarem®, a gadolinium-based contrast agent. |
|
Scientific Title of Study
|
Active surveillance in India of the safety of Dotarem®, a gadolinium-based contrast agent. Post-marketing observational, surveillance study |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DGD-55-007, Protocol Version 1.0, dated 16-Dec-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Amel Antony |
| Designation |
HOD & Senior Consultant |
| Affiliation |
Lisie Hospital |
| Address |
MRI Reporting room,1st
floor, Lisie Institute of
Radiology reasearch
and Imaging sciences
Lisie Hospital Rd North
Kaloor 682018
Ernakulam
Ernakulam
KERALA
682018
India |
| Phone |
9847166707 |
| Fax |
|
| Email |
amelantony@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somesh Bolegave |
| Designation |
Deputy General Manager - Medical Services |
| Affiliation |
Siro Clintech Private Limited |
| Address |
Siro Clintech Private Limited
ASMACO house, Plot no B 41, Road no 27, Wagle industrial estate, Thane 400604.
Landmark - near ITI
Thane
MAHARASHTRA
400604
India |
| Phone |
9969205149 |
| Fax |
02261088045 |
| Email |
somesh.bolegave@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somesh Bolegave |
| Designation |
Deputy General Manager - Medical Services |
| Affiliation |
Siro Clintech Private Limited |
| Address |
Siro Clintech Private Limited
ASMACO house, Plot no B 41, Road no 27, Wagle industrial estate, Thane 400604.
Landmark - near ITI
Thane
MAHARASHTRA
400604
India |
| Phone |
9969205149 |
| Fax |
02261088045 |
| Email |
somesh.bolegave@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
| GUERBET, B.P. 57400, 95943 Roissy CdG Cedex, France |
|
|
Primary Sponsor
|
| Name |
GUERBET |
| Address |
B.P. 57400, 95943 Roissy CdG Cedex, FRANCE |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
| Name |
Address |
| Ms Rutuja Bhonsle |
Guerbet India Pvt Ltd.
Omega House, 402, 4th Floor,
Main Street, Hiranandani Gardens,
Powai, Andheri (E), Mumbai - 400076 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zafar Abbas |
ESIC Medical College and hospital |
ESIC Medical College and hospital NH3 NIT Faridabad Haryana- 121001 India
Faridabad
HARYANA |
9891260448
szarz@rediffmail.com |
| Dr Amel Antony |
Lisie Hospital |
MRI Reporting room,1st floor,
Lisie Institute of
Radiology reasearch
and Imaging sciences
Lisie Hospital Rd North
Kaloor 682018
Ernakulam
Ernakulam
KERALA |
9847166707
amelantony@ymail.com |
| Dr Bharat Aggarwal |
Max Super specialty Hospital |
Radiology Services, Radiology Department, Max Super specialty Hospital Saket West Block ( A unit of Max healthcare Institute Limited), 1 Press enclave road, Saket New Delhi, 110017
South
DELHI |
9810077484
Bharat.Aggarwal@maxhealthcare.com |
| Dr Anisha Gehani |
Tata Medical Center |
Department of Radiology, 14 MAR (EW), Newtown, Rajarhat, Kolkata- 700160
Kolkata
WEST BENGAL |
7003484110
anisha.gehani@tmckolkata.com |
| Dr Suyash Kulkarni |
Tata Memorial Hospital, Mumbai |
Room no 72,Ground floor,Main building,
Department Of
Radio-Diagnosis Tata
Memorial Hospital, Dr.
Ernest Borges Road,
Parel, Mumbai-400012
Mumbai
MAHARASHTRA |
9869488867
suyashkulkarnitmh@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for ESIC Faridabad ESIC Medical College And Hospital |
Approved |
| Institutional Ethics Committee Lisie Hospital |
Approved |
| Institutional Review Board of Tata Medical Center |
Approved |
| Max Healthcare Ethics Committee |
Approved |
| TMH, Institutional Ethics Committee-II |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R90-R94||Abnormal findings on diagnostic imaging and in function studies, without diagnosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gadolinium-based contrast Agent (Dotarem) |
Dotarem is formulated at a gadolinium concentration of 0.5M. The recommended dose of Dotarem® is 0.1 mmol/kg body weight (BW), with higher doses up to 0.3 mmol/kg BW in exceptional cases according to Summary of Product Characteristics. Patients will be administered Dotarem® before the contrast-enhanced MRI and will be followed up for 6 (+/- 2)weeks for any safety concerns. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female patients aged at least 18 years or older
2.Patients for whom Dotarem®-enhanced MRI exam is confirmed
3.Patient who did not previously receive any gadolinium-based contrast agent GBCA
4.Patient having agreed to participate in the active surveillance and agree to be contacted by phone after 6 ± 2 weeks after the MR scan for brief interview
|
|
| ExclusionCriteria |
| Details |
There are no exclusion criteria. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Collection of any AEs immediately post-dose and 6 (±2) weeks after Dotarem® administration. |
1.Immediately post-dose
2.6 (±2) weeks post administration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Description of the reported adverse events after use of Dotarem® in terms of seriousness, causal relationship, duration, latency, outcome and additional gadolinium-based contrast agent (GBCA) administration. |
1.Immediately post-dose
2.6 (±2) weeks post administration
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/11/2024 |
| Date of Study Completion (India) |
30/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a post-marketing observational, surveillance study of
Dotarem® in India.
Patients will be informed about the active surveillance by site personnel.
For patients who agree to participate, GBCA administration and follow-up call
will be documented by site personnel.
During the follow-up phone call, the patients will be asked by
open, non-directing questions about adverse experience after exposure to
Dotarem®. Up to two attempts will be made to contact a patient.
The site personnel will complete the eCRF on the day of Dotarem®
administration (Day 1) and on the day of the follow-up call.
All patients scheduled for contrast-enhanced MRI with Dotarem®
will be invited to participate in the study. The recruitment of patients within each site will be open for
approximately 6 months or until 65 patients are included, whichever is shorter. Healthcare professionals (HCP, such as physician, nurse, radiology
technician) at each site will be trained on Dotarem® safety, protocol and
applicable pharmacovigilance requirements.
|