Status:
COMPLETED
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Lead Sponsor:
Guerbet
Conditions:
Diagnostic Self Evaluation
Central Nervous System Diseases
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be comp...
Detailed Description
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how ...
Eligibility Criteria
Inclusion
- Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
- Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
- Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.
- Has been fully informed about the study, and has consented to participate.
Exclusion
- Having acute or chronic grade IV or V renal insufficiency.
- Known class III/IV congestive heart failure.
- Suffering from long QT syndrome.
- Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
- Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.
- Known allergy to Gadolinium chelates.
- Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.
- Pregnant, breast feeding, or planning to become pregnant during the trial.
- Previously participated in this trial.
- Having participated within 30 days in another clinical trial involving an investigational drug.
- Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
- Inability or unwillingness to cooperate with the requirements of this trial.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT01211873
Start Date
September 1 2010
End Date
November 1 2011
Last Update
April 18 2019
Active Locations (52)
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1
University of Alabama at Birmingham, UABMC
Birmingham, Alabama, United States, 35233
2
University Medical Center
Tucson, Arizona, United States, 47404
3
University medical center
Tucson, Arizona, United States, 85724
4
Desert Medical Imaging
Indian Wells, California, United States, 47404