| CTRI Number |
CTRI/2021/11/037705 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
08/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
A study to check the effects of drug ProHance in patients undergoing Magnetic Resonance Imaging
(MRI) of whole body during routine clinical practice in India. |
|
Scientific Title of Study
|
A Multicenter, Prospective, Non-Comparative, Non-Randomized,
Open Label, Phase IV clinical trial to evaluate safety and efficacy of
ProHance in patients undergoing Contrast Enhanced Magnetic
Resonance Imaging (CE-MRI) of the whole body during routine
clinical practice in India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PH-110 Final Version Amendment No 02 Dated 25 October 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin 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 Malle |
| Designation |
Chief Executive Officer |
| 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, United States of America |
|
|
Primary Sponsor
|
| Name |
Bracco Diagnostics Inc |
| Address |
259 Prospect Plains Rd. Building H, Monroe Township, NJ 08831,
United States of America |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Imaging Products India Pvt Ltd |
D-117, TTC Industrial Area, Village Shiravane,
Nerul, Navi Mumbai – 400 706, Maharashtra |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kshitij Jain |
Arihant Diagnostic Centre |
First Floor,23,Jagannathpuri Colony, Rathyatra-Mahmoorgani Road, Varanasi-10
Varanasi
UTTAR PRADESH |
919415624180
MishravibhutiI6@gmail.com |
| Dr Deepak Patkar |
Dr. Balabhai Nanavati Hospital |
Department of Imaging and Radiology, S.V. Road, Vile Parle (West), Mumbai -400056
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9821136677
deepak.patkar@nanavatihospital.org |
| Dr Ashok Kumar Verma |
GSVM Medical College |
Department of Radio-Diagnosis, GSVM Medical College,Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH |
9452679918
ashokve@gmail.com |
| Dr Vinoth Saravanan |
Mahatma Gandhi Medical College and Research Institute |
Radiology Department
Ground Floor, Pondicherry - Cuddalore Rd, ECR, Pitlayarkuppam, Puducherry 607 402
Pondicherry
PONDICHERRY |
919443169286
mvs7771@gmail.com |
| Dr Jayalatha Nethagani |
MNJ Institute of Oncology and Regional Cancer Centre |
Department of
Radiology, Red hills
Road, Beside Niloufer
Hospital, Lakdi ka pul,
Hyderabad - 500004
Hyderabad
TELANGANA |
9701544047
jayanethagani@gmail.com |
| Dr Saugata Sen |
Tata Medical Centre |
Department of
Radiology and Imaging,
14, MARE (E-W), DH
Block, Action Area I,
New Town Kolkata-
700160
Kolkata
WEST BENGAL |
9830448007
drsaugatasen@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. Balabhai Nanavati Hospital |
Approved |
| Ethics Committee, GSVM Medical College |
Approved |
| Institutional Human Ethics Committee Mahatma Gandhi Medical College and Research Institute |
Approved |
| MNJ Institute of Oncology and Regional Cancer Centre, Institutional Ethics Committe |
Approved |
| Samvedna Hospital Ethics Committee |
Approved |
| Tata Medical Centre, Institutional 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 |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ProHance |
Gadoteridol 279.3 mg/ml
Intravenous injection once rapid bolus dose.The recommended dose of ProHance for whole body MRI is 0.1 mmol/kg (corresponding to 0.2. ml/kg). |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Provides written Informed Consent and is willing to comply with protocol requirements;
2 Is male or female of at least 2 years of age;
3 Is scheduled to undergo whole-body CE-MRI with exception of CNS and head/neck MRI. |
|
| ExclusionCriteria |
| Details |
1.Is a pregnant or lactating female. Exclude the possibility of pregnancy:
1.1.by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the
start of investigational product administration,
1.2.by surgical history (e.g., tubal ligation or hysterectomy),
1.3.post-menopausal with a minimum 1 year without menses;
2.Has any known allergy to one or more of the ingredients of the investigational product or
has a history of hypersensitivity to any metals;
3.Has received or scheduled to receive an investigational compound within 30 days before
admission into this study;
4.Has severe renal impairment, defined as GFR/eGFR < 30 ml/min/1.73m2
5.Has previously entered this study;
6.Has any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical
clips) or any other conditions that would preclude proximity to a strong magnetic field;
7.Is suffering from severe claustrophobia;
8.Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objective, or completing the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To expand the safety profile in subjects administered ProHance for CE-MRI of the whole body with exception of CNS and head/neck MRI. |
Upto 30 minutes following completion of the MRI
examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of ProHance from the practical use of ProHance in CE-MRI of the whole body with exception of CNS and head/neck MRI. |
Upto 30 minutes following completion of the MRI
examination |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
27/02/2022 |
| Date of Study Completion (India) |
23/05/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this Phase IV post-marketing study is to evaluate and provide information related to safety and efficacy of ProHance in patients undergoing CE-MRI of the whole body with ProHance in routine clinical practice, to Drug Controller General-India (DCGI) to meet national regulatory requirements for therapeutic product registration. Completion of all study related procedures will take up to a maximum of three days for each subject. Study participation will begin at the time the subject/parent signs informed consent, which can be done up to 24 hours prior to the MRI procedure taking place. The MRI procedure will take approximately 40 minutes. Safety monitoring will begin at the time of signing the Informed Consent Form and ends up to 30 minutes following completion of the MRI examination. Kidney function will be assessed through serum creatinine at 24 hours prior to ProHance administration and between 24-48 hours post ProHance administration. |