Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT03023566
Eligibility Criteria:
Inclusion Criteria:
* Any patient under 18 years of age who is scheduled for contrast enhanced MRI examination as part of their standard of care.
* Patients who are willing to undergo contrast enhanced MRI procedure
* Patients who are willing to comply with the study procedures (e.g. being followed-up for 24 hours after MRI procedure).
* Patients who have given their fully informed and written consent voluntarily.
Exclusion Criteria:
* Patients receiving an MRI exam without contrast.
* Patients who are pregnant, lactating or who are \> 11 years old and have not had a negative urine pregnancy test the same day as administration of Dotarem. The manufacturer's instructions for performing the urinary pregnancy test are to be followed.
* Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
* Patients with a Glomerular Filtration Rate (GFR) \< 30.
* Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any investigational drug during the 24 (+ / - 4) hour safety follow-up period.
* Not being able to remain lying down for at least 45 - 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
* Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents .
* Patients who have received any other contrast medium within 24 hours prior to Dotarem injection or are scheduled to receive any other contrast medium within the follow-up period.
* Being clinically unstable and whose clinical course during the 24 (+ / - 4) hours observation period is unpredictable.
* Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period.
* Having any contraindication to MRI examination (e.g. pacemaker, recent wound clips, and severe claustrophobia).
* Having been previously enrolled in this study.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT03023566
Study Brief:
Protocol Section:
NCT03023566