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CTRI Number  CTRI/2024/04/066403 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 24/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Active Surveillance 
Study Design  Single Arm Study 
Public Title of Study   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 
Scientific Title of Study   Active surveillance of the safety of Gadolinium-based contrast agent(s) in India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Dated 21.04.2022  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaibhav Hublikar 
Designation  Therapeutic Area Head Radiology 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Bayer House Central Avenue Hiranandani Estate Thane west

Thane
MAHARASHTRA
400607
India 
Phone  7506210386  
Fax    
Email  vaibhav.hublikar@bayer.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vaibhav Hublikar 
Designation  Therapeutic Area Head Radiology 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Bayer House Central Avenue Hiranandani Estate Thane west


MAHARASHTRA
400607
India 
Phone  7506210386  
Fax    
Email  vaibhav.hublikar@bayer.com  
 
Details of Contact Person
Public Query  
Name  Dr Vaibhav Hublikar 
Designation  Therapeutic Area Head Radiology 
Affiliation  Bayer Pharmaceuticals Private Limited 
Address  Bayer Pharmaceuticals Private Limited Bayer House Central Avenue Hiranandani Estate Thane west


MAHARASHTRA
400607
India 
Phone  7506210386  
Fax    
Email  vaibhav.hublikar@bayer.com  
 
Source of Monetary or Material Support  
Bayer Pharmaceuticals Pvt.Ltd. 
 
Primary Sponsor  
Name  Bayer Pharmaceuticals Pvt Ltd 
Address  Bayer House, Central Avenue, Hiranandani Estate, Thane West, Maharashtra- 400607  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Viren Shah  Aman Hospital & Research Center  Aman Hospital & Research Center, 15, Shaswat, Opp ESI Hospital, Gotri Road, Vadodara - 390021.
Vadodara
GUJARAT 		 9825172710

viren340@hotmail.com 
Dr Utkarsh Kabra  Getwell Diagnostic Centre  MRI Reporting Room, Dept. Of Radiology, Getwell Poly Clinic and Hospital, JLN Marg Jaipur, 302005
Jaipur
RAJASTHAN 		 9829062622

utkarsh.kabra@gmail.com 
Dr Mitusha Verma  Nanavati Max Super Speciality Hospital  Nanavati Max Super Speciality Hospital, SV Rd, Vile Parle (W), Mumbai - 56,        Maharashtra
Mumbai
MAHARASHTRA 		 7506731013

mitusha.verma@nanavatihospital.org 
Dr Padavala Satish  Pramodini Medicare Private Limited  CSI complex, Andhra Hospital 29-4-54K, Prakasam Rd, opp. Heart & Brain Institute, Vijayawada – 520002, Andhra Pradesh, India.
Krishna
ANDHRA PRADESH 		 9989398970

padavalasatish@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Independent Ethics Committee - Fusion Clinical Research  Approved 
Indira IVF Hospital Ethics Committee  Approved 
Institutional Ethics Committee - Aman Hospital & Research Center  Approved 
Institutional Ethics Committee - Dr. Balabhai Nanavati Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R948||Abnormal results of function studies of other organs and systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  There is no specific exclusion criteria. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To detect all prospective adverse events immediately post dose and 6 (±2) weeks after
administration of branded GBCA. 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To estimate the reporting rate of adverse events after use of a branded GBCA.  6 weeks 
 
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   N/A 
Date of First Enrollment (India)   08/05/2024 
Date of Study Completion (India) 29/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
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   GBCAs are regarded as safe with few adverse events of usually mild to moderate severity. However, there are publications in the medical literature reporting that, following the administration of gadolinium-based contrast agents (GBCAs), traces of gadolinium can be retained for months or years in several organs. To date, clinical consequences of gadolinium retention have not been established in patients with normal renal function.Further, there were adverse reaction reports from post-marketing surveillance that reported adverse events with variable onset and duration, without an established causal link to gadolinium retention. Reported events include fatigue, asthenia, pain syndromes, and heterogeneous clusters of symptoms in the neurological, cutaneous, and musculoskeletal systems. Active surveillance will be achieved by GBCA brand specific recruitment and follow-up of consecutive GBCA naïve patients who agree to participate.At first contact, patients determined to require GBCA-enhanced MRI will be asked for permission to be contacted by phone 6 (±2) weeks after the MRI scan. Sentinel sites will keep a log of questionnaires for all eligible patients. Patients will be informed about the active surveillance by site personnel. For patients who agreed to participate, GBCA administration will be documented by site personnel. In follow-up phone calls after 6 (±2) weeks, each patient who consented will be asked by open, non-directing questions about adverse experience after exposure to the GBCA. Up to two attempts will be made to contact a patient.After each patient contact, the questionnaire will immediately be reviewed for reported adverse events. The MA holder will be notified immediately about any adverse event by a copy of the questionnaire and, if available, supportive documents. Adverse event reports will be handled by the MAH as solicited post-marketing reports and reported in line with regulatory requirements. After completion, questionnaires will be forwarded to the MAH for preparation of a final report and archiving. Each MAH will prepare a GBCA brand specific final report within 6 months after the last scheduled interview. The report will present descriptive statistics, stratified by sentinel site and counts of adverse event reports. In addition, the GBCA brand specific report will summarize adverse experience by MedDRA system organ classes and MedDRA preferred terms, by case and event seriousness, by reporter and company assessment of causal relationship, by latency (i.e., interval between injection of GBCA and onset of adverse event), by duration, by outcome, by number of GBCA administrations (confounded cases), and by expectedness (India).   
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