MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Lesion Detection
研究概览
简要总结
The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.
详细描述
Gadopiclenol is a new macrocyclic gadolinium-based contrast agent (GBCA) which has higher relaxivity than other GBCAs with a potential use of lower dose and comparable pharmacokinetics to other agents in preclinical studies. In a rodent model of liver metastasis, gadopiclenol showed strong enhancement with comparable pharmacokinetics to other extracellular GBCAs (EC-GBCAs). It was found to have a potential of either improving lesion conspicuity or providing similar accuracy in lesion detection with a reduced Gadolinium (Gd) dose. In a rat brain tumor model, half dose (0.05 mmol/kg) of gadopiclenol yielded comparable contrast-to-noise ratio (CNR) and morphological characterization of brain tumors compared to other EC-GBCAs. There are also a few clinical studies in which no safety concern was raised with the use of gadopiclenol. No dose adjustment for children or patients with renal impairment was found to be required. There is no study in the literature assessing the enhancement properties of gadopiclenol in abdominal imaging and comparing it with a hepatobiliary agent for image quality and lesion detection/conspicuity in the liver. For this study, it is hypothesized that dynamic imaging using Gadopiclenol is noninferior to gadoxetate MRI in terms of image quality and lesion detection/conspicuity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients of both genders and all ethnic groups with clinical indication of MRI for chronic liver disease and/or focal lesion and/or tumor treatment follow-up.
排除标准
- •Acute renal insufficiency.
- •Severe chronic renal insufficiency (GFR <30 mL/min/1.73 m2).
- •Age <18y.
- •Unable or unwilling to give informed consent.
- •Contraindications for MRI (such as pacemakers, infusion pumps, pregnancy, allergy or previous adverse reactions to gadolinium contrast agents, severe claustrophobia).
研究组 & 干预措施
Liver
Patients who have had clinically indicated MRI scans for liver lesions.
干预措施: Radiology (Other)
Liver
Patients who have had clinically indicated MRI scans for liver lesions.
干预措施: Gadopiclenol (Other)
结局指标
主要结局
Lesion Detection
时间窗: End of study, at 6 months
Lesion detection (for any enhancing lesions including benign and malignant lesions, excluding cysts and completely necrotic treated malignant lesions) will be evaluated both for gadopiclenol-enhanced study (including unenhanced sequences from index MRI) and gadoxetate-enhanced MRI (the reference standard method): will be classified for each post- contrast phase as 0: no visible enhancing lesion, 1: visible enhancing lesion.
次要结局
- Liver lesion conspicuity(End of study, at 6 months)
研究者
Sara Lewis
Professor
Icahn School of Medicine at Mount Sinai
