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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05691634
Acronym
TATOU - IRM
Enrollment
3000
Registered
2023-01-20
Start date
2023-02-01
Completion date
2025-02-28
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRI, Tattoo Disorder

Keywords

Tattoo disorder, MRI

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.

Interventions

PROCEDUREMRI

Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).

OTHERLikert scale questionnaire

The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)

Sponsors

Cimror
CollaboratorUNKNOWN
Elsan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of MRIs resulting in at least one complication in patients with tattoos.1 dayComplications 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.

Countries

France

Contacts

Primary ContactChristine Bagard
christine.gimbergues@laposte.net04 73 74 78 38
Backup ContactDuband Sandrine
sduband@polesanterepublique.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026