Imaging Multiple Sclerosis Lesions Using Magnevist and Gadavist
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|ClinicalTrials.gov Identifier: NCT01836055|
Recruitment Status : Terminated (The study didn't have sufficient flow of subjects (discontinued by the Sponsor))
First Posted : April 19, 2013
Last Update Posted : December 9, 2014
- 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 research project is to see if the newer contrast agent is able to detect changes and differentiate healthy from affected tissue in the white matter and gray matter earlier than current contrast agents so that detection can be possible before major damage occurs to the tissue. Each person will be scanned initially with one agent and then between 8 and 30 days later with the other agent. The MR data processing results will be compared to check the efficacy of each contrast agent.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Observational Model:||Case Control|
|Official Title:||Comparing Lesion Contrast With Both Magnevist and Gadavist and Understanding the Cerebral Perfusion Patterns of Patients With Multiple Sclerosis (MS) Using Magnetic Resonance Imaging (MRI)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||February 2014|
Clinically Isolated Syndrome
Patients diagnosed with Clinically Isolated Multiple Sclerosis
Relapsing Remitting MS
Patients diagnosed with Relapsing Remitting Multiple Sclerosis
Aged Matched Healthy volunteers
- Lesion detection and quantification in Multiple Sclerosis Patients [ Time Frame: 8 to 30 days ]
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.
- MR cerebral blood flow Quantification [ Time Frame: 8 to 30 days ]
Secondary Study Objective(s): To quantify MR cerebral blood flow (CBF) with PWI in the same cohort described above.
Hypothesis: MS patients will show reduced CBF compared to age-matched healthy subjects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836055
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Ewart M. Haacke, PhD||Wayne State University|