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CTRI Number  CTRI/2021/03/032302 [Registered on: 25/03/2021] Trial Registered Prospectively
Last Modified On: 28/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Post marketing surveillance study on patients referred for contrast enhancement MRI of various organs including brain, spinal cord, breast, liver and kidney 
Scientific Title of Study   A Prospective, Open label Multi-center, post marketing surveillance study to Evaluate the Efficacy and Safety of a Single Intravenous Injection of 0.1 mmol/kg Body Weight of Viv-butrol in patients referred for contrast enhancement MRI of various organs including brain, spinal cord, breast, liver and kidney 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PMS/Vivere/Viv-butrol Version 1.0 Dated 20th Oct 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vishnu Vempat 
Designation  Vice President, Business Development 
Affiliation  Vivere Imaging Private Limited 
Address  Plot 92, 1-98/2/92, Kavuri Hills, Phase II, Jubilee Hills, Hyderabad Telangana

Hyderabad
TELANGANA
500033
India 
Phone  8008556380  
Fax    
Email  v.vempati@vivereimaging.com  
 
Details of Contact Person
Scientific Query  
Name  DrJagadeesh B Rangisetty 
Designation  Director  
Affiliation  Vivere Imaging Private Limited 
Address  Plot 92, 1-98/2/92, Kavuri Hills, Phase II, Jubilee Hills, Hyderabad Telangana

Hyderabad
TELANGANA
500033
India 
Phone  9000016421  
Fax    
Email  info@vivereimaging.com  
 
Details of Contact Person
Public Query  
Name  DrJagadeesh B Rangisetty 
Designation  Director  
Affiliation  Vivere Imaging Private Limited 
Address  Plot 92, 1-98/2/92, Kavuri Hills, Phase II, Jubilee Hills, Hyderabad Telangana

Hyderabad
TELANGANA
500033
India 
Phone  9000016421  
Fax    
Email  info@vivereimaging.com  
 
Source of Monetary or Material Support  
Vivere Imaging Private Limited Plot 92, 1-98/2/92, Kavuri Hills, Phase II, Jubilee Hills, Hyderabad Telangana 500033 
 
Primary Sponsor  
Name  Vivere Imaging Private Limited 
Address  Plot 92, 1-98/2/92, Kavuri Hills, Phase II, Jubilee Hills, Hyderabad Telangana 500033  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Biophore India Pharmaceuticals Pvt Ltd  Plot#92; 1-98/2/92, Kavuri Hills – Phase II, Jubilee Hills, Hyderabad- 33; Telangana, India 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrT Arul Dasan  Bangalore Medical College and Research Institute  Fort Rd, near City Market, New Tharagupet, Department of Radiodiagnosis Victoria Campus Room no 5 Grounf Floor Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9739312244

arul_dsn@yahoo.co.in 
DrSuneeth J  ESIC Medical College & Hospital  department of Radiology Gorund floor Room no 5 7-1-634, Survey No.121/1 & 121/2, National Highway 65, Sanjeeva Reddy Nagar, Sanath Nagar, Hyderabad, Telangana
Hyderabad
TELANGANA 		 9441210456

suneeth.charlton@gmail.com 
DrSharath Chandra   Rajiv Gandhi Institute Of Medical Sciences (RIMS) General Hospital  Basement room no 2 Shanti Nagar Colony, Balaga, Srikakulam, Andhra Pradesh 532001
Srikakulam
ANDHRA PRADESH 		 9912320517

clinicalresearchblr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics commitee-Bangalore Medical College and Research Institute  Approved 
Institutional Ethics Committe Medical college & Government General Hospital - Government   Approved 
Institutional Ethics Committe-ESIC Medical College & Hospital-ESIC Medical College & Hospital,   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L581||Chronic radiodermatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Viv-butrol  Dosage: Injection Dose:0.1 mmol/kg Body Weight Duration:1 day follow up: 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Males and females of age 18 and older
2. Requiring Gadolinium contrast enhanced MRI for organs including brain, spinal cord, breast, liver and kidney
3. Ability to understand study procedures and to comply with them for the entire length of the study
4. Lab Eligibility parameters (for contrast scans within 4 weeks of gadolinium injection):
a. Creatinine below upper normal limit
b. eGFR greater than or equal to 60 mL/min/1.73m2
5. Able to understand and sign informed consent
6. Willing to follow up telephonically for 6 months
7. No MRI scan with gadolinium injection in the last 6 months 
 
ExclusionCriteria 
Details  1. Is a female patient who is pregnant or lactating
2. Has any contraindication to the MRI examination (e.g. metal implants). Implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damages from twisting in a Magnetic field. Examples: (Aneurysm clip, implanted neural stimulator, Implanted cardiac pacemaker, defibrillator, or certain other implanted electrical or metallic devices, Cochlear implant, ocular foreign body (metal shavings), Any implanted device (pumps, infusion devices, etc.), Shrapnel injuries, History of metal in head or eyes or other parts of the body.
3. Morbid obese/or a body circumference that prevents the study subject from lying flat in the scanner
4. Untreatable claustrophobia otherwise requiring anesthesia.
5. Has received any contrast agent within 24 hours prior to the study, or is scheduled to receive any contrast agent within 24 hours after the study.
6. GBCA (gadolinium based contrast agents) with an MRI scan in the last 6 months. This includes scan performed with GBCA at any outside institution and/or at the clinical center.
7. Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [<14 days], unstable angina, congestive heart failure New York Heart Association class IV) or acute stroke (< 48 hours)).
8. Has acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period or who has acute or chronic moderate or severe renalinsufficiency (glomerular filtration rate < 60 mL/min/1.73m2).
9. Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
10. Contraindications to the administration of gadobutrol (depending on local product label).
11. History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents.
12. History of allergic asthma.
13. Individuals with a history of liver transplant or severe liver disease.
14. Individuals with hemoglobinopathies
15. Surgery of uncertain type as per investigators opinion
16. Considered clinically unstable as per investigator’s opinion
17. Any contraindications that the investigator identifies from the subject and/or History and Physical findings for MRI examination and/ gadobutrol.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Adverse effects monitoring  Day 0,Day 30, Day 60,Day 90,Day 120,Day 150 and Day 180.

 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of Sum of lesion visualization parameters between Viv-butrol enhanced MRI vs unenhanced (plain) MRI
Parameters assessed on Visualization Scoring System
1. Border delineation
2. Contrast enhancement
3. Internal morphology
 		 Day 0 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   30/03/2021 
Date of Study Completion (India) 17/03/2022 
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  
Gadolinium-containing MRI contrast agents are most commonly used for the enhancement of vessels in MR angiography or for brain tumor enhancement associated with the degradation of the blood–brain barrier. (Rajiv Mahajan et al. 2019) Gadobutrol is a second-generation, multipurpose, nonionic extracellular, macrocyclic GBCA2,3 provided in a 1 M concentration. In addition to its unique 1 M concentration, gadobutrol features the highest relaxivity (the measure for the strength of a GBCA to shorten relaxation times) of all macrocyclic GBCAs 2,4,5 . The major determinant for signal and contrast enhancement in MRI is shortening of relaxation times of (water) protons. Due to gadobutrol’s high relaxivity and double concentration, it achieves the highest T1 shortening per mL of all GBCAs.4 Furthermore, as a macrocyclic contrast agent, gadobutrol provides high chelate stability with substantially less—if any— in vivo release of Gd ions as compared with linear GBCAs.6 The stability of Gd chelates has been linked to an increased risk of nephrogenic systemic fibrosis (NSF) in patients with severely impaired renal function.7,8 Because of these favorable characteristics, gadobutrol was categorized as a low-risk GBCA for development of NSF by several medical organizations5,9 and authorities.1 (Jan Endrikat et al. 2017)
 
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