| CTRI Number |
CTRI/2023/06/054128 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Post Marketing study to check safety of the MRI Contrast Dye. |
|
Scientific Title of Study
|
Active Surveillance Study of the Safety of MultiHance®
in India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| F.No. ND/CT-04/FF/2022/34976 |
DCGI |
| OBS-BII-002, Final Version, Dated 01 August 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin D Pawar |
| Designation |
Director - Operations |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office NO. 604, 6th Floor, Shelton Cubix Plot No. 87, Sector 15, CBD Belapur
Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
Sachin.P@Clinicaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar B Malle |
| Designation |
Medical Monitor |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office NO. 604, 6th Floor, Shelton Cubix Plot No. 87, Sector 15, CBD Belapur
Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
drajay.m@Clinicaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Pravinkumar Pal |
| Designation |
Clinical Project Manager |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office NO. 604, 6th Floor, Shelton Cubix Plot No. 87, Sector 15, CBD Belapur
Navi Mumbai
Thane
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
Pravinkumar.Pal@Clinicaresearch.com |
|
|
Source of Monetary or Material Support
|
| Bracco Diagnostics, Inc.
259 Prospect Plains Rd. Building H
Monroe Township, NJ 08831 |
|
|
Primary Sponsor
|
| Name |
Bracco Diagnostics, Inc. |
| Address |
259 Prospect Plains Rd. Building H
Monroe Township, NJ 08831, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Imaging Products India Pvt Ltd |
D117, TTC Industrial Area, Nerul, Navi Mumbai-400706, Maharashtra, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashok Kumar Verma |
Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College |
Department of Radio-Diagnosis, Ground Floor, GSVM Medical College,Swaroop Nagar, Kanpur -208002
Kanpur Nagar
UTTAR PRADESH |
9452679918
ashokve@gmail.com |
| Dr Jyotsna Rani Paladugu |
Nizams Insitute of Medical Sciences |
Department of Radiology and Imageology, Ground Floor, Punjagutta Road, Punjagutta Market, Punjagutta, Hyderabad - 500082
Hyderabad
TELANGANA |
9849988000
yjyotsna@yahoo.com |
| Dr Geena Benjamin |
Pushpagiri Medical College Hospital |
Department of Radio-diagnosis, Ground Floor, MC Road, Thiruvalla - 689101
Pathanamthitta
KERALA |
9847147347
geenabenjamin@gmail.com |
| Dr Devidas Dahiphale |
Sahyadri Diagnostic Centre |
First Floor, Plot No. 15, Gajanan Maharaj Mandir Road, Garkheda, Seven Hills, Aurangabad-431001
Aurangabad
MAHARASHTRA |
9850901993
dr.devidasdahiphale@gmail.com |
| Dr Saugata Sen |
Tata Medical Center |
Department of Radiology, First Floor, 14, Major Arterial Road (EW), Newtown, Rajarhat, Kolkata- 700160
Kolkata
WEST BENGAL |
9830448007
drsaugatasen@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College |
Approved |
| Institutional Ethics Committee of Shraddha Hospital and Critical Care Centre |
Approved |
| Institutional Ethics Committee Pushpagiri Institute of Medical Science |
Approved |
| NIMS Institutional Ethics Committee |
Approved |
| Tata Medical Center Institutional Review Board |
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 |
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 brain and Spine: 0.2 mL/Kg of the 0.5M Solution
MRA: 0.2 mL/Kg of the 0.5M Solution
MRI of the breast: 0.2 mL/Kg of the 0.5M Solution
The Product should be administered intravenously either as a bolus or slow injection (10mL/min).
The Injection should be followed by a flush of Sodium Chloride 9mg/ml (0.9%) solution for injection.
Duration of Intervention: Once |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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? |
|
| ExclusionCriteria |
| Details |
1. Did the subject receive prior GBCA?
2. Was the subject already included in the study? |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prospective Assessment of adverse events (AEs) |
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 Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
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)
|
27/06/2023 |
| Date of Study Completion (India) |
09/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 Active Surveillance Study Protocol is aimed at supporting the National Coordination Centre-Pharmacovigilance Programme of India in monitoring the safety of MultiHance® through a better characterization of the associated ADRs and the identification of specific risk factors.
The objective of the current study is to actively survey patients for longer than it is typically done during the development studies of GBCAs for 6 (±2) weeks after the administration of MultiHance® and determine the occurrence of late AEs that could be possibly associated with its administration. |