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

• Sponsor: Elsan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05691634
• Collaborator: Cimror (Other)
• Enrollment: 3,000
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 250.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tattoo Disorder; MRI	Procedure: MRI; Other: Likert scale questionnaire	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 3000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Prospective Study Evaluating the Clinical Tolerance of Skin Tattoos During MRI Examinations (TATOU - IRM)
• Anticipated Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with tatoo	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)

Outcome Measures

Primary Outcome Measures

1. Proportion of MRIs resulting in at least one complication in patients with tattoos. [1 day]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pôle Santé République	Clermont-Ferrand		France	63100

Sponsors and Collaborators

• Elsan
• Cimror

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elsan
• ClinicalTrials.gov Identifier: NCT05691634
• Other Study ID Numbers: 2021-A02758-33
• First Posted: Jan 20, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Elsan: Tattoo disorder; MRI

Study Results

No Results Posted as of Jan 20, 2023