EUCTR2007-005363-10-FR进行中（未招募）不适用
Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement (CIS patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS
C.H.U. de RENNES0 个研究点开始时间: 2007年12月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.age between 18 and 45 years
- •2.Patients with a CIS—defined as a first neurologic event suggestive of MS lasting for at least 24 hours and with symptoms and signs indicating a single lesion (monofocal)
- •3.Presence of a first monosymptomatic neurologic event suggestive of MS that lasted for at least 24 hours
- •4.Presence of at least two clinically silent lesions on their T2-weighted brain MRI baseline scan
- •5.With an Expanded Disability Status Scale (EDSS) score at baseline between 0 and 5
- •6.USPIO (SH U 555 C) injection has to be performed within four weeks after start of clinical event
- •7.Patients have to be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection
- •8.Patients must be compliant with study protocol
- •9.Patients must have given their written consent to participate in this study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Non-adult patients
- •2.Any patients not fulfilling the criteria of a monosymptomatic clinically isolated syndrome suggestive of multiple sclerosis
- •3.Any monosymptomatic CIS patients being included after four weeks of clinical onset of their neurologic symptoms
- •4.Any monosymptomatic CIS patients having received steroid treatment before acquisition of the baseline USPIO MR scan
- •5.Patients in whom any disease other than MS could explain their signs and symptoms,
- •6.Patients with any previous episode that could possibly be attributed to an acute demyelinating event will be excluded,
- •7.Patients with complete transverse myelitis or bilateral optic neuritis will be excluded,
- •8.Patients who had received prior immunosuppressive or immunomodulatory treatment will be excluded.
- •9.Patients which cannot be in-patients for a minimum of 24 hours after the first USPIO (SH U 555 C) injection
- •10.Female patients without efficient contraception (oral or others)
- •11.Pregnant patients
- •12.Lactating patients
- •13.Patients with a past history of anaphylactoid reaction
- •14.Patients with a past history of bronchial asthma or any other allergic disorder
- •15.Patients with a past history for a lower threshold of seizures
- •16.Patients with a past history for a lower threshold of seizures
- •17.Patients with a past history of severe cardiovascular disease
- •18.Patients with a past history or evidence of moderate or severe renal failure (GFR < 60ml/min)
- •19.Any patient presenting with a known contra-indication for MR scanning, for example:
- •a.Cardiac or cerebral pacemaker
- •b.Iron containing surgical implants
- •c.Cochlear implants
- •d.Intracerebral or intraocular iron-containing foreign bodies
- •20.Non-compliant or uncooperative patients with regard to study protocol
- •21.Patients having previously been included in this study
- •22.Patients already participating in another ongoing diagnostic or therapeutic study
- •23.Patients non-eligible for social benefits
- •24.Patients under guardianship
- •25.Patients not having given their written consent to participate in this study
- •26.Any patient with an accompanying systemic disease, cardiac disease or mental disorder
研究者
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