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

NCT ID: NCT05691634

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tattoo Disorder MRI

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient with tatoo

Group Type EXPERIMENTAL

MRI

Intervention Type PROCEDURE

Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).

Likert scale questionnaire

Intervention Type OTHER

The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

Patient with a tatoo will perform an MRI. The possible symptoms during the MRI or after MRI will then be described (duration, type,...).

Intervention Type PROCEDURE

Likert scale questionnaire

The patient will appreciate his feeling after MRI on a Likert scale (from 1 to 5)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cimror

UNKNOWN

Sponsor Role collaborator

Elsan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pôle Santé République

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christine Bagard

Role: CONTACT

04 73 74 78 38

Duband Sandrine

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christine BAGARD, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-A02758-33

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MRL in the Upper Extremity
NCT04575636 COMPLETED NA
Imaging Techniques in MRI
NCT01130545 RECRUITING
Improve MRI Diagnosis
NCT05744102 NOT_YET_RECRUITING NA