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 compared to the results of MRI taken without Dotarem.
Brief Title
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
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 well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Diagnostic Self Evaluation
Central Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
* 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 Criteria:
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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.
* 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.
Gender
All
Gender Based
false
Keywords
CNS
Contrast Agent
MRI
Dotarem
Magnevist
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
2 Years
NCT Id
NCT01211873
Org Class
Industry
Org Full Name
Guerbet
Org Study Id
DGD-44-050
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
Primary Outcomes
Outcome Description
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.
Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI.
The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI.
The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
Outcome Measure
MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
Outcome Time Frame
up to 24 hours
Secondary Outcomes
Outcome Description
Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality.
Outcome Time Frame
up to 24 hours
Outcome Measure
Image Quality Score
Outcome Description
Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5).
Outcome Time Frame
up to 24 hours
Outcome Measure
Diagnostic Confidence Score
Outcome Description
The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient
Outcome Time Frame
up to 24 hours
Outcome Measure
Number of Lesions
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
2
Investigators
Investigator Type
Principal Investigator
Investigator Name
Michael Lipton
Investigator Email
michael.lipton@einsteinmed.org
Investigator Phone
718-430-2416/718.430.3390