Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)

Conditions
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MRI, Tattoo Disorder

Intervention / Treatment
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* Procedure: MRI
* Other: Likert scale questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Minor 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with tatoo<br> | Procedure: MRI<br>* Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).<br>Other: Likert scale questionnaire<br>* The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of MRIs resulting in at least one complication in patients with tattoos. | 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. | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tattoo disorder, MRI