Health Condition 1: L581- Chronic radiodermatitis
Conditions
Interventions
Intervention1: Viv-butrol: Dosage: Injection
Dose:0.1 mmol/kg Body Weight
Duration:1 day
follow up: 6 months
Control Intervention1: NIL: NIL
Sponsors
Vivere Imaging Private Limited
Biophore India Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 [ 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse effects monitoringTimepoint: Day 0,Day 30, Day 60,Day 90,Day 120,Day 150 and Day 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Timepoint: Day 0 | — |
Countries
India
Contacts
Public ContactDrJagadeesh B Rangisetty
Vivere Imaging Private Limited
Outcome results
None listed