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Recruiting
NCT05691634
Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
Conditions: Tattoo Disorder, MRI
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 3000
Sponsor: Elsan
Location: France
Summary
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.
Eligibility Criteria
Inclusion Criteria:Major patienttattoo patientAbility to answer the questionnaireAffiliated patient or beneficiary of a social security schemePatient having been informed and not objecting to the researchExclusion Criteria:MinorPatient unable to understand and respond to questionnaires due to language difficulties or cognitive impairmentPatient objecting to researchPregnant or breastfeeding womanProtected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Source: ClinicalTrials.gov (NCT05691634). StuddyBuddy aggregates publicly available trial information.