CTRI/2021/03/032302已完成4 期
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
Vivere Imaging Private Limited0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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