NCT05691634

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tattoo Disorder
• MRI

Interventions

Type	Name	Description
PROCEDURE	MRI	Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).
OTHER	Likert scale questionnaire	The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-08-01
• Completion: 2025-02-01
• First posted: 2023-01-20
• Last updated: 2024-02-29

Locations

1 site across 1 country: France