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
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Adverse effects monitoring
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of age 18 and older
- •Requiring Gadolinium contrast enhanced MRI for organs including brain, spinal cord, breast, liver and kidney
- •Ability to understand study procedures and to comply with them for the entire length of the study
- •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
- •Able to understand and sign informed consent
- •Willing to follow up telephonically for 6 months
- •No MRI scan with gadolinium injection in the last 6 months.
排除标准
- •Is a female patient who is pregnant or lactating
- •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.
- •Morbid obese/or a body circumference that prevents the study subject from lying flat in the scanner
- •Untreatable claustrophobia otherwise requiring anesthesia.
- •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.
- •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)).
- •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).
- •Is scheduled or likely to require a surgery and/or biopsy in the time period up to 24 hours following study drug application
- •Contraindications to the administration of gadobutrol (depending on local product label).
- •History of severe allergic or anaphylactic/anaphylactoid reaction to any allergen including drugs and contrast agents.
- •History of allergic asthma.
- •Individuals with a history of liver transplant or severe liver disease.
- •Individuals with hemoglobinopathies
- •Considered clinically unstable as per investigator’s opinion
- •Any contraindications that the investigator identifies from the subject and/or History and Physical findings for MRI examination and/ gadobutrol.
结局指标
主要结局
Adverse effects monitoring
时间窗: Day 0,Day 30, Day 60,Day 90,Day 120,Day 150 and Day 180.
次要结局
- Comparison of Sum of lesion visualization parameters between Viv-butrol enhanced MRI vs unenhanced (plain) MRI(Parameters assessed on Visualization Scoring System)