Evaluating how skin tattoos react during MRI exams
Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
This study is testing how tattoos react during MRI scans to see if they cause any problems, like tingling or burns, for people with tattoos.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Elsan Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05691634 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the complications that may arise during MRI examinations for patients with skin tattoos. It focuses on understanding the potential risks, such as tingling sensations or burns, that could occur due to the interaction between tattoo pigments and the magnetic field of the MRI. Participants will undergo MRI scans and complete a Likert scale questionnaire to report their experiences. The study seeks to clarify the safety of MRI procedures for tattooed individuals.
Who should consider this trial
Good fit: Ideal candidates include adult patients with tattoos who can understand and respond to questionnaires.
Not a fit: Patients who are minors, unable to communicate effectively, or who object to participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety protocols for MRI examinations in patients with tattoos.
How similar studies have performed: While there is limited data on this specific interaction, similar studies have raised concerns about the safety of MRI in tattooed individuals, indicating a need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clermont-Ferrand
- Pôle Santé République — Clermont-Ferrand, France (Recruiting)
Study contacts
- Study coordinator: Christine Bagard
- Email: christine.gimbergues@laposte.net
- Phone: 04 73 74 78 38
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.