Post marketing surveillance study on patients referred for contrast enhancement MRI of various organs including brain, spinal cord, breast, liver and kidney
- Conditions
- Health Condition 1: L581- Chronic radiodermatitis
- Registration Number
- CTRI/2021/03/032302
- Lead Sponsor
- Vivere Imaging Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
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
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 investigatorââ?¬•s opinion
17. Any contraindications that the investigator identifies from the subject and/or History and Physical findings for MRI examination and/ gadobutrol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse effects monitoringTimepoint: Day 0,Day 30, Day 60,Day 90,Day 120,Day 150 and Day 180. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Comparison of Sum of lesion visualization parameters between Viv-butrol enhanced MRI vs unenhanced (plain) MRI <br/ ><br>Parameters assessed on Visualization Scoring System <br/ ><br>1. Border delineation <br/ ><br>2. Contrast enhancement <br/ ><br>3. Internal morphology <br/ ><br>Timepoint: Day 0