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NCT01836055 · ClinicalTrials.gov registry record
Imaging Multiple Sclerosis Lesions Using Magnevist and Gadavist
A clinical trial, sponsored by Wayne State University.
- Terminated
- Registry status
- 19
- Enrollment target
NCT01836055: Clinical Trial study, sponsored by Wayne State University.
NCT01836055 is a clinical trial that was terminated before completion, run by Wayne State University. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01836055 was terminated before completion, sponsored by Wayne State University.
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
Study Summary
* The investigators are conducting a magnetic resonance imaging (MRI) study comparing two MRI contrast agents in people with clinically isolated syndrome and relapsing remitting multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter in the brain. MRI is used as a gold standard to visualize the degenerative changes in the brain and spine. The neurologist will usually order an MRI to confirm the diagnosis of MS using conventional imaging methods. These images reveal two main pieces of information regarding (a) the location of the lesions and (b) the status of the lesions. While the location of the lesions directly correlates with the clinical symptoms, the information about the status of the lesions informs the neurologist whether the lesion is new (active) or old (chronic). * This ability to differentiate new and old lesions requires the use of a contrast agent. Currently, used agents reveal some lesions but it is unclear if they reveal the full extent of the disease. In new lesions, there may be a leakiness in the blood vessels and if the contrast agent leaks out then the investigators can see this. In healthy controls, the blood brain barrier is usually intact and this leak does not happen. One open question is: "can the extravasation of the contrast agent to the brain precede the major tissue damage that we see in the structural MRI?" * Recently, a new FDA approved contrast agent (Gadavist) has been released and has enhanced characteristics in terms of affecting the MR signal resulting in a better contrast in the image and therefore, better diagnosis of the status of the disease. Given its high relaxivity, a small amount of Gadavist may show a better signal enhancement affected tissue for multiple sclerosis patients. The investigators hypothesize that Gadavist will reveal more tissue damage (lesions) than Magnevist and, therefore, may present a better tool for early diagnosis of brain damage. * The investigators' goal in this resear
Primary Outcome
Primary Study Objective(s): To quantify lesion contrast in MS patients (RRMS and CIS) compared to normal controls using either Magnevist or Gadavist in a comparative study. All subjects will undergo another MRI scan after a period of 8 to 30 days using either Magnevist or Gadavist depending on their initial contrast agent use. Both are extravascular agents and hence are expected to show MS lesions well. Hypothesis: MS lesions will be better visualized with Gadavist.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-02 |
Why NCT01836055 stopped before completion
NCT01836055 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01836055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01836055 about?
NCT01836055 is a clinical study titled "Imaging Multiple Sclerosis Lesions Using Magnevist and Gadavist". * The investigators are conducting a magnetic resonance imaging (MRI) study comparing two MRI contrast agents in people with clinically isolated syndrome and relapsing remitting multiple sclerosis (MS). MS is a disease that affects the white matter and gray matter in the brain. MRI is used as a gold...
What is the current status of trial NCT01836055?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2012-01. Estimated completion is 2014-02.
Who is sponsoring clinical trial NCT01836055?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
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