Evaluation of Regional Gadolinium Retention in the Brain Using QSM With Correlation to Regional DCE MRI Permeability Using GOCART Technique in Intracranial Neoplasm Patients Receiving Gadobenate Dimeglumine (MultiHance) or Gadoterate Meglumine (Dotarem)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in QSM score
研究概览
简要总结
This randomized pilot clinical trial studies quantitative susceptibility mapping (QSM) and regional dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) permeability using golden-angle cartesian randomized time-resolved (GOCART) technique in evaluating regional gadolinium retention in the brain in patients with intracranial neoplasm receiving gadobenate dimeglumine or gadoterate meglumine. MRI diagnostic techniques such as, QSM and DCE MRI, may help to gather information regarding brain changes associated with gadolinium deposits during 8 to 18 months after administration of gadobenate dimeglumine or gadoterate meglumine.
详细描述
PRIMARY OBJECTIVES:
I. To obtain preliminary data (e.g. mean, variance, distribution) in the regional brain parenchymal changes associated with gadolinium (Gd) deposition during 8 to 18 months period after administration of gadolinium based contrast agents (GBCA) to Gd naive intracranial neoplasm patients who will be randomized to gadobenate dimeglumine (MultiHance) or gadoterate meglumine (Dotarem).
II. To explore if areas of increased regional Gd deposition at individual level are correlated with baseline regional DCE permeability metrics such as volume transfer coefficient reflecting vascular permeability (kTrans), extracellular volume ratio reflecting vascular permeability (ve) and plasma volume (vp) in intracranial neoplasm patients.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care QSM and T1 weighted imaging (T1WI). Patients then receive gadobenate dimeglumine intravenously (IV) and undergo GOCART DCE MRI over 60 minutes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with suspected intracranial neoplasm scheduled for routine MRI with GBCA (gadolinium naive patients)
- •Willingness to comply with the study protocol
排除标准
- •Contraindications for MRI or GBCA (standard of care)
- •Abnormal renal function with estimated glomerular filtration rate (eGFR) less than 30 mL/min/m^2 based on creatinine obtained within last 30 days
- •History of previous administration of GBCA
研究组 & 干预措施
Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadobenate dimeglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Device)
Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadobenate dimeglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Gadobenate Dimeglumine (Drug)
Arm I (QSM, T1WI, gadobenate dimeglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadobenate dimeglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Magnetic Resonance Imaging (Device)
Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Dynamic Contrast-Enhanced Magnetic Resonance Imaging (Device)
Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Gadoterate Meglumine (Drug)
Arm II (QSM, T1WI, gadoterate meglumine, GOCART DCE MRI)
Patients undergo standard of care QSM and T1WI. Patients then receive gadoterate meglumine IV and undergo GOCART DCE MRI over 60 minutes.
干预措施: Magnetic Resonance Imaging (Device)
结局指标
主要结局
Change in QSM score
时间窗: Baseline up to 18 months
Descriptive statistics will be used to describe the magnitude of Gd deposition measured by QSM score in each of the two study groups. Histograms will be generated for QSM score at each time point as well as the change from the baseline for each group. The descriptive statistics will be used to calculate the mean, median, interquartile range, and standard deviation. Box plot and overlying histogram will be used to illustrate the distribution of change in Gd deposition between gadobenate dimeglumine and gadoterate meglumine group. Correlation between QSM score versus (vs.) kTrans and QSM score v
次要结局
- Change in T1WI signal intensity ratio(Baseline up to 18 months)
- kTrans and Ve signal using GOCART 3D MRI(Up to 18 months)