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

MRI Clinical Trial

— TATOU - IRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05691634
• Other study ID #: 2021-A02758-33
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Elsan
• Contact: Christine Bagard
• Phone: 04 73 74 78 38
• Email: christine.gimbergues[@]laposte.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• MRI

Intervention

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)

Locations

Country	Name	City	State
France	Pôle Santé République	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
Elsan	Cimror

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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