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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05691634
Other study ID # 2021-A02758-33
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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