Comparing Lesion Contrast With Both Magnevist and Gadavist and Understanding the Cerebral Perfusion Patterns of Patients With Multiple Sclerosis (MS) Using Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Lesion detection and quantification in Multiple Sclerosis Patients
研究概览
简要总结
- The investigators are conducting a magnetic resonance imaging (MRI) study comparing two MRI contrast agents in people with clinically isolated syndrome and relapsing remitting multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter in the brain. MRI is used as a gold standard to visualize the degenerative changes in the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis of MS using conventional imaging methods. These images reveal two main pieces of information regarding (a) the location of the lesions and (b) the status of the lesions. While the location of the lesions directly correlates with the clinical symptoms, the information about the status of the lesions informs the neurologist whether the lesion is new (active) or old (chronic).
- This ability to differentiate new and old lesions requires the use of a contrast agent. Currently, used agents reveal some lesions but it is unclear if they reveal the full extent of the disease. In new lesions, there may be a leakiness in the blood vessels and if the contrast agent leaks out then the investigators can see this. In healthy controls, the blood brain barrier is usually intact and this leak does not happen. One open question is: "can the extravasation of the contrast agent to the brain precede the major tissue damage that we see in the structural MRI?"
- Recently, a new FDA approved contrast agent (Gadavist) has been released and has enhanced characteristics in terms of affecting the MR signal resulting in a better contrast in the image and therefore, better diagnosis of the status of the disease. Given its high relaxivity, a small amount of Gadavist may show a better signal enhancement affected tissue for multiple sclerosis patients. The investigators hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and, therefore, may present a better tool for early diagnosis of brain damage.
- The investigators' goal in this research project is to see if the newer contrast agent is able to detect changes and differentiate healthy from affected tissue in the white matter and gray matter earlier than current contrast agents so that detection can be possible before major damage occurs to the tissue. Each person will be scanned initially with one agent and then between 8 and 30 days later with the other agent. The MR data processing results will be compared to check the efficacy of each contrast agent.
详细描述
Rationale/Goal: The use of contrast agents in magnetic resonance imaging (MRI) has been a gold standard in diagnosing multiple sclerosis (MS). One active lesion (i.e. enhanced after the injection of contrast agent) is one of the major McDonald criteria in diagnosis patients with MS and request further follow up. Therefore, it is of great importance to study the characteristics of contrast agents and their ability to cross the blood brain barrier and enhance lesions, and thus understand the mechanism underlying this debilitating disease. It is the aim of this proposal to compare lesion load visualization in MS patients using Magnevist and Gadavist contrast agents and show reduced whole brain perfusion of MS patients compared to healthy subjects. This proposal will allow us to investigate the increase in angiogenic sensitivity to contrast agent (Gadavist), in addition to testing the ability to differentiate the breakdown of blood brain barrier.
METHODS
-Study Design: Fifty-four (54) subjects will be enrolled in this study including 36 MS patients and 18 healthy subjects as age and gender-matched controls over a one year period. Approval from Wayne State University Institutional Review Board (IRB) will be obtained before the beginning of this study. All the participants will sign an informed consent form after being told about the study and its possible associated risks. We propose to study 18 relapsing remitting MS (RRMS) patients and 18 clinically isolated syndrome (CIS) patients and 18 normal controls. The subjects will be scanned at entry and a second time (scan 2) - no sooner than 8 days after the first scan but no later than 30 days after the first scan. Every effort will be made to scan them as close as possible to the 8 day period.
Nine RRMS and nine CIS patients will undergo an MR scan using Magnevist first (scan 1 at entry) then Gadavist (scan 2) while the other nine in each category will undergo an MR scan using Gadavist first (scan 1 at entry) then Magnevist (scan 2). Eighteen normal subjects will undergo the same protocol described above for MS patients, 9 with one order (Magnevist then Gadavist) and 9 with the other (Gadavist then Magnevist), to be used as age and gender matched controls for data analysis. Patients will be recruited by physicians affiliated with the Detroit Medical Center (DMC) and surrounding areas.
MR Protocol
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MS Patients:
- •Patients who suffer from clinically definite MS with a RR phenotype or CIS
- •Age range from 20-59 years old
- •Not pregnant or nursing
- •Able to understand and sign a consent form
- •No contraindication to MRI and contrast agent
- •Control is a healthy volunteer
- •Aged from 20-59 years old
- •Not pregnant or nursing
- •Able to understand and sign a consent form
- •No contraindication to MRI and contrast agent
排除标准
- •MS Patients:
- •History of other major illness such as diabetes, chronic renal disease, a prior known neurological disorder other than MS or substances abuse
- •Currently receiving chemo therapy, on dialysis
- •Known contraindication to MRI such as pacemaker, pregnancy, other non-MR compatible implanted device
- •Allergic to MRI contrast Patients with moderate to severe kidney disease that have impaired ability to filter the contrast agents (serum creatinine > 1.8 mg/dL).
- •Younger than 20 or older than 59
- •Pregnancy or nursing
- •Unable to understand and sign a consent form
- •History of other major illness such as diabetes, chronic renal disease, a prior known neurological disorder or substances abuse
- •Currently receiving chemo therapy, on dialysis
- •Known contraindication to MRI such as pacemaker, pregnancy, other non-MR compatible implanted device
- •Allergic to MRI contrast Controls with moderate to severe kidney disease that have impaired ability to filter the contrast agents (serum creatinine > 1.8 mg/dL).
- •Younger than 20 or older than 59
- •Pregnancy or nursing
- •Unable to understand and sign a consent form
结局指标
主要结局
Lesion detection and quantification in Multiple Sclerosis Patients
时间窗: 8 to 30 days
Primary Study Objective(s): To quantify lesion contrast in MS patients (RRMS and CIS) compared to normal controls using either Magnevist or Gadavist in a comparative study. All subjects will undergo another MRI scan after a period of 8 to 30 days using either Magnevist or Gadavist depending on their initial contrast agent use. Both are extravascular agents and hence are expected to show MS lesions well. Hypothesis: MS lesions will be better visualized with Gadavist.
次要结局
- MR cerebral blood flow Quantification(8 to 30 days)
研究者
E.Mark Haacke
Director
Wayne State University