Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2008-01-31
2011-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
NCT01211873
Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
NCT04373564
Evaluation of Potential Accumulation of Gadolinium (Dotarem and Multihance) in the French Observatory of Multiple Sclerosis (Www.Ofsep.Org/)
NCT02992847
Kinetics of Urinary Excretion of Gadolinium Contrast Agents Used in MRI Examinations
NCT06191731
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
NCT03023566
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dotarem®-enhanced MRI
Patients undergoing Dotarem®-enhanced MRI for diagnostic purposes
Dotarem®-enhanced MRI
Single IV administration before MRI exam
Non-enhanced MRI
Patients undergoing non-enhanced MRI for diagnostic purposes
non-enhanced MRI
non injected MRI
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dotarem®-enhanced MRI
Single IV administration before MRI exam
non-enhanced MRI
non injected MRI
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient with a known stable renal insufficiency ;
* Patient scheduled to undergo an MRI examination to specify a diagnosis ;
* Patient able to understand and provide written informed consent to participate in the trial ;
Exclusion Criteria
* Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;
* Patient who needs hemodialysis ;
* Patient with known allergy to gadolinium chelates ;
* Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;
* Patients planned to either undergo surgery or receive chemotherapy ;
* Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
* Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
* Patient with newly discovered unstable diabetes.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guerbet
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gilbert Deray, Pr, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Pitie-Salpetriere
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onze Lievevrouwziekenhuis
Aalst, , Belgium
University Hospital Ghent
Ghent, , Belgium
Alg. Inwendige Ziekten -Nierziekten
Roeselare, , Belgium
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hôpital A. Calmette
Lille, , France
Hôpital Edouard Herriot
Lyon, , France
Hopital Pitie Salpetriere
Paris, , France
Hopital Bichat
Paris, , France
Hôpital Tenon
Paris, , France
CHU Strasbourg
Strasbourg, , France
Hôpital Trousseau
Tours, , France
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, , Italy
Ente Ospedaliero Ospedali Galliera,
Genova, , Italy
Hospital San Carlos
Madrid, , Spain
Hospital Dr PESET
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DGD-44-044
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.