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

Not Applicable

Recruiting

• Conditions: Tattoo Disorder; MRI
• Interventions: Procedure: MRI; Other: Likert scale questionnaire

• Registration Number: NCT05691634
• Lead Sponsor: Elsan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-20
• Study Start: 2023-02-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29
• Primary Completion: 2024-08
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with tatoo	MRI	-
Patient with tatoo	Likert scale questionnaire	-

Primary Outcome Measures

Name	Time	Method
Proportion of MRIs resulting in at least one complication in patients with tattoos.	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.

Trial Locations

Locations (1)

Pôle Santé République; 🇫🇷 Clermont-Ferrand, France