Phase 3
N=402
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Diagnostic Self Evaluation · Central Nervous System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01211873 ↗Enrolled (actual)
402
Serious AEs
0.5%
Results posted
May 2014
Primary outcome: Primary: MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation — 1.06; 3.30; 1.62; 4.49 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dotarem (gadoterate meglumine) (Drug); Magnevist (gadopentetate dimeglumine) (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation |
1.06; 3.30; 1.62; 4.49; 1.43; 2.54 | <0.001 sig |
| SECONDARY Image Quality Score |
1.41; 2.98; 1.42; 2.96; 1.72; 3.00 | <0.001 sig |
| SECONDARY Diagnostic Confidence Score |
3.04; 4.59; 3.11; 4.66; 2.84; 4.89 | <0.001 sig |
| SECONDARY Number of Lesions |
1.97; 2.69; 1.98; 4.19; 2.29; 3.16 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01211873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.