| CTRI Number |
CTRI/2020/10/028449 [Registered on: 16/10/2020] Trial Registered Prospectively |
| Last Modified On: |
31/08/2021 |
| 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 brain, spine, head and neck 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 brain/spine and head and neck during routine clinical practice in India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PH-109 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajaykumar Malle |
| Designation |
Chief Executive Officer |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No. 103, First Floor, Raheja Arcade, Plot No 61, Sector 11, CBD Belapur, Navi Mumbai
Mumbai
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
drajay.m@clinicaresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajaykumar Malle |
| Designation |
Chief Executive Officer |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No 103, First Floor Raheja Arcade, Plot No 61, Sector 11, CBD Belapur, Navi Mumbai
Mumbai
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
drajay.m@clinicaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Pawar |
| Designation |
Director - Operations |
| Affiliation |
CLINICA Research Solutions LLP |
| Address |
Office No. 103, First Floor, Raheja Arcade, Plot No 61, Sector 11, CBD Belapur, Navi Mumbai
Mumbai
MAHARASHTRA
400614
India |
| Phone |
02249705627 |
| Fax |
|
| Email |
Sachin.P@clinicaresearch.com |
|
|
Source of Monetary or Material Support
|
|
|
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 |
|
|
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 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 |
9821136677
deepak.patkar@nanavatihospital.org |
| Dr Supreethi Kohli |
ESI Hospital and PGIMSR |
Room No. 54, CTMRI Centre, Department of Radio- Diagnosis, Basaidarapur, New Delhi-110015
West
DELHI |
9310059122
suprkohli@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= 5 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. Balabhai Nanavati Hospital |
Approved |
| Institutional Ethics Committee, ESI-PGIMSR |
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: G939||Disorder of brain, unspecified, |
|
|
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. |
|
|
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 CE-MRI:
3.1 Subjects ≥ 2 years of age: CE-MRI for Brain (intracranial), Spine and Associated tissues
3.2 Subjects ≥ 18 years of age: CE-MRI for Head and Neck
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
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 |
| Monitoring Adverse Events. 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 |
Upto 30 minutes following completion of the MRI examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diagnosis: Normal’ or ‘Abnormal’ MRI scan.
Diagnostic gain due to Contrast agent:
1)Improved lesion delineation (border definition, lesion morphology)
2)Minimized differential diagnoses
3)Allowed definitive diagnosis not possible on pre-contrast scans
4)Allowed identification of lesions not seen on pre-contrast scans
5)Contributed to exclusion of disease
6)Contribution influenced patient management |
Post 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)
|
14/04/2021 |
| Date of Study Completion (India) |
31/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet Planned |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 for brain/spine and head and neck 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 a maximum of 1 day for each subject. Study participation will begin at the time the subject 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. |