Gadobutrol Versus Gadopentetate Dimeglumine or Gadobenate Dimeglumine
Dynamic Contrast Enhanced Steady State T1-Weighted Perfusion MRI (DCE MRI): Characterization of Intracranial Lesions
What it found
The trial ended early for another reason (see below).
Reason given: Insufficient Accrual
This trial finished 12 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Given for the study's measurements
- Dynamic Contrast-Enhanced Magnetic Resonance Imaging
- Gadobenate dimeglumine
Diagnostic agent
- Gadobutrol
Diagnostic agent
- Gadopentetate Dimeglumine
What it measured
Main measures
Agreement of using Magnevist® or Multihance versus Gadavist® on glioma grading
Up to 7 days
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* Confirmed diagnosis of multiple sclerosis, known or suspected diagnosis of glioma, or known or suspected diagnosis of cerebral metastasis * Scheduled or to be scheduled for a follow-up MRI per standard of care for their disease * Minimum permitted time intervals from prior treatments are 6 weeks for intracranial surgery * Adequate renal function (serum creatinine =\< 1.5 mg/dL) * Subject must sign a study-specific informed consent
Exclusion criteria
* Medically unstable * Renal impairment (glomerular filtration rate [GFR] \< 60 mL/min/1.73m\^2) or history of existing nephrogenic systemic fibrosis (NSF) * Cardiac pacemaker * A serious concurrent infection, illness, or medical condition * Subjects with any surgical clip, external clips, or any other ferromagnetic device, that is contraindicated for use in MRI * Subject is claustrophobic and cannot cooperate for the MRI * Females who are pregnant or nursing * Any other condition that would compromise the scan with reasonable safety
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This pilot clinical trial compares gadobutrol with standard of care contrast agents, gadopentetate dimeglumine or gadobenate dimeglumine, before dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain. Gadobutrol is a type of contrast agent that may increase DCE-MRI sensitivity for the detection of tumors or other diseases of the central nervous system. It is not yet known whether gadobutrol is more effective than standard of care contrast agents before DCE-MRI in diagnosing patients with multiple sclerosis, grade II-IV glioma, or tumors that have spread to the brain.
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History
Started
Dec 2011
Main results due
Oct 2014
Finished
Oct 2015