Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATO… (NCT05691634) | Clinical Trial Compass
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Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
France3,000 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of MRIs resulting in at least one complication in patients with tattoos.