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临床试验/NCT05177718
NCT05177718终止4 期

Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年9月16日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
1
试验地点
1
主要终点
Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans

研究概览

简要总结

In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

详细描述

The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.

As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • multiple sclerosis
  • clinical eligibility to treatment with Natalizumab
  • no previous exposure to Natalizumab treatment

排除标准

  • inability to perform an MRI with contrast
  • inability to undergo a paper-pencil questionnaires and blood work

研究组 & 干预措施

Treatment Single Arm

Other

SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV

干预措施: Natalizumab 300 MG in 15 ML Injection (Drug)

结局指标

主要结局

Effect of Natalizumab on Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability: K-trans

时间窗: 12 months

To measure changes in k-trans between baseline (pre-treatment) and month-3 and month-12 post-treatment scan

次要结局

  • Effect of Natalizumab on Magnetic Resonance Imaging Measures of Myelin Integrity: Pool Saturation Ratio (PSR)(12 months)

研究者

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

Francesca Bagnato

Assistant Professor

Vanderbilt University Medical Center

研究点 (1)

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