Pilot Study of Delayed, 24 Hour Imaging of Hepatocellular Carcinoma Following the Administration of the Hepatobiliary MRI Contrast Agent Gadolinium Ethoxybenzyl Dimeglumine (Eovist)
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases
研究概览
简要总结
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors.
详细描述
Before the research starts (screening): After signing the consent form, the participant will be asked to undergo some screening tests or procedures to find out if they can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant does not take part in the research study. If the participants has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- An assessment of your tumor by X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans.
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study. If the participant does not meet the eligibility criteria, they will not be able to participate in this research study.
After the screening procedures confirm that the the participant is eligible to participate in the research study:
In this research study, the investigators are looking to see if MR imaging with Eovist performed 24 hours after the injection of Eovist helps improve the identification and characterization of focal liver tumors. Currently, standard Eovist-enhanced MRI examinations include imaging up to 20 minutes after the injection of Eovist. The participant will undergo a routine, standard of care Eovist MRI examination of the liver. The participant will then be asked to return on the following day so that a repeat MRI examination may be performed at approximately 24 hours after your dose of Eovist. No additional injections will be performed on the 2nd day of imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- •Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma.
- •Participants must be scheduled to undergo an Eovist-enhanced MRI of the liver as a part of their standard of care.
- •Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with MRI.
- •Because no dosing or adverse event data are currently available on the use of Eovist in participants <18 years of age, and because HCC is exceedingly rare in the pediatric population, children are excluded from this study.
- •The effects of Eovist on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- •Participants who have had chemotherapy, radiofrequency ablation, microwave ablation, chemo-embolization, or radiotherapy within 4 weeks prior to entering the study.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to Eovist.
- •Patients with glomerular filtration rates < 30 mL/min/1.73m
- •Patients who are unable to undergo MRI imaging.
- •Patients who are pregnant.
研究组 & 干预措施
Eovist at 24 Hour Delayed Imaging
This study will evaluate uptake of the hepatobiliary magnetic resonance imaging (MRI) contrast agent gadolinium ethoxybenzyl dimeglumine, or Eovist (Bayer Imaging, Wayne, NJ) within hepatocellular carcinomas (HCCs) at delayed, 24 hour imaging. The recommended dose of Eovist is 0.1 mL/kg, or 0.025 mmol/kg.
干预措施: Eovist (Drug)
结局指标
主要结局
Calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases
时间窗: 24 hours
The primary objective is to calculate the percent absolute enhancement of HCCs following Eovist administration at multiple phases: arterial enhancement, portal venous enhancement, hepatobiliary enhancement, and late washout enhancement.All but the final phase of imaging are performed as part of routine clinical care and occur within the first 20 minutes. This study will investigate the behavior of HCCs with regards to Eovist enhancement at a late washout phase, which occurs after 24 hours. The primary outcome is evidence of absolute enhancement within HCC at the late washout phase.
次要结局
未报告次要终点
研究者
Mukesh Harisinghani, MD
Principal Investigator
Massachusetts General Hospital