Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
TATOU - IRM
1 other identifier
interventional
3,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2023
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFebruary 29, 2024
February 1, 2024
1.5 years
January 9, 2023
February 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Patient with tatoo
EXPERIMENTALInterventions
Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).
The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pôle Santé République
Clermont-Ferrand, 63100, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2023
First Posted
January 20, 2023
Study Start
February 1, 2023
Primary Completion
August 1, 2024
Study Completion
February 1, 2025
Last Updated
February 29, 2024
Record last verified: 2024-02