Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Proportion of MRIs resulting in at least one complication in patients with tattoos.
研究概览
简要总结
MRI examinations are potential sources of complications related to the displacement of ferromagnetic objects, but also to heating effects that can go as far as burns. This overheating can be caused by contact with external equipment (sensors, cables, etc.). Patients with skin tattoos may experience specific complications as tingling or "burning" felt at the site of the tattoo. They can be followed by a transient erythema with edema around the reversible tattoo in 12 and 72 hours. One observation of severe 2nd degree burns has been reported. They would be linked to the presence of metallic salts in the dermis, resulting from interactions between the pigments and the magnetic field but their mechanisms are poorly identified and divergent.
The aim of this study is to assess the rate of MRI causing complications in patients with tattoos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Major patient
- •tattoo patient
- •Ability to answer the questionnaire
- •Affiliated patient or beneficiary of a social security scheme
- •Patient having been informed and not objecting to the research
排除标准
- •Patient unable to understand and respond to questionnaires due to language difficulties or cognitive impairment
- •Patient objecting to research
- •Pregnant or breastfeeding woman
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
研究组 & 干预措施
Patient with tatoo
干预措施: MRI (Procedure)
Patient with tatoo
干预措施: Likert scale questionnaire (Other)
结局指标
主要结局
Proportion of MRIs resulting in at least one complication in patients with tattoos.
时间窗: 1 day
Complications are defined by the occurrence of symptoms felt by the patient (tingling, stinging, burning, redness, swelling) and by the occurrence of side effects visible to the operator (redness, oedema/tumefaction, others) and confirmed by the investigator present during the examination.
次要结局
未报告次要终点