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Imaging Multiple Sclerosis Lesions Using Magnevist and Gadavist

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Wayne State University
Sponsor:
Information provided by (Responsible Party):
E.Mark Haacke, Wayne State University
ClinicalTrials.gov Identifier:
NCT01836055
First received: April 8, 2013
Last updated: April 16, 2013
Last verified: April 2013
  Purpose
  • 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
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:


Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Lesion detection and quantification in Multiple Sclerosis Patients [ Time Frame: 8 to 30 days ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • MR cerebral blood flow Quantification [ Time Frame: 8 to 30 days ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 54
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Clinically Isolated Syndrome
Patients diagnosed with Clinically Isolated Multiple Sclerosis
Relapsing Remitting MS
Patients diagnosed with Relapsing Remitting Multiple Sclerosis
Control Subjects
Aged Matched Healthy volunteers

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Fifty-four subjects will be recruited in this study including 18 RRMS patients, 18 CIS patients and 18 control subjects. Patients will be recruited by physicians affiliated with the Detroit Medical Center (DMC), Oakland Hospital in Detroit, MI and other local hospitals and physicians. Patients with prior known neurological disorders other than MS or substances abuse, with contraindication to MRI such as pacemaker, pregnancy, other non-MR compatible implanted device as well as with moderate to severe kidney disease that have impaired ability to filter the contrast agents will be excluded from the study. Brain MRI scans will be obtained once at entry as we will be running a cross sectional study. Controls will be recruited from the university environment in Detroit and the surrounding areas.

Criteria

Inclusion Criteria:

MS Patients:

  • Patients who suffer from clinically definite MS with a RR phenotype or CIS
  • Age range from 20-59 years old
  • Not pregnant or nursing
  • Able to understand and sign a consent form
  • No contraindication to MRI and contrast agent

Controls:

  • Control is a healthy volunteer
  • Aged from 20-59 years old
  • Not pregnant or nursing
  • Able to understand and sign a consent form
  • No contraindication to MRI and contrast agent

Exclusion Criteria:

MS Patients:

  • History of other major illness such as diabetes, chronic renal disease, a prior known neurological disorder other than MS or substances abuse
  • Currently receiving chemo therapy, on dialysis
  • Known contraindication to MRI such as pacemaker, pregnancy, other non-MR compatible implanted device
  • Allergic to MRI contrast Patients with moderate to severe kidney disease that have impaired ability to filter the contrast agents (serum creatinine > 1.8 mg/dL).
  • Younger than 20 or older than 59
  • Pregnancy or nursing
  • Unable to understand and sign a consent form

Controls:

  • History of other major illness such as diabetes, chronic renal disease, a prior known neurological disorder or substances abuse
  • Currently receiving chemo therapy, on dialysis
  • Known contraindication to MRI such as pacemaker, pregnancy, other non-MR compatible implanted device
  • Allergic to MRI contrast Controls with moderate to severe kidney disease that have impaired ability to filter the contrast agents (serum creatinine > 1.8 mg/dL).
  • Younger than 20 or older than 59
  • Pregnancy or nursing
  • Unable to understand and sign a consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836055

Contacts
Contact: Anamika Chaudhary, M.S. 3137451378 anamikachoudhary@gmail.com
Contact: Kingsley J. Yang, PhD 3139338771 kingsleyang@gmail.com

Locations
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Anamika Chaudhary, M.S.    313-745-1378    anamikachoudhary@gmail.com   
Contact: Kingsley J. Yang, PhD    313-993-8771    kingsleyang@gmail.com   
Principal Investigator: Ewart M. Haacke, PhD         
Sponsors and Collaborators
Wayne State University
Investigators
Principal Investigator: Ewart M. Haacke, PhD Wayne State University
  More Information

Publications:

Responsible Party: E.Mark Haacke, Director, Wayne State University
ClinicalTrials.gov Identifier: NCT01836055     History of Changes
Other Study ID Numbers: DI-2011-33
Study First Received: April 8, 2013
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wayne State University:
Multiple Sclerosis
White Matter Lesions
Contrast Agent
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014