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临床试验/NCT06596616
NCT06596616Enrolling By Invitation不适用

MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年7月1日最近更新:
适应症
干预措施

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Lewis

Professor

Icahn School of Medicine at Mount Sinai

研究点 (2)

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