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Vessel Wall Imaging for Diagnosis and Monitoring of Central Nervous System (CNS) Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03166319
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : June 26, 2019
Information provided by (Responsible Party):
Vance Lehman, Mayo Clinic

Brief Summary:
This is a prospective pilot study to determine the utility of MRI and high resolution intracranial vessel wall imaging for the diagnosis and disease activity assessment of intracranial vasculitis.

Condition or disease Intervention/treatment Phase
Vasculitis, CNS Vasculitis, Cerebral Device: MRI, including intracranial vessel wall imaging Not Applicable

Detailed Description:

This study will evaluate patients with suspected primary angiitis of the central nervous system (PACNS), recruited during initial work-up by our multi-disciplinary team. Given the low incidence of CNS vasculitis and the fact that some patients are routed to a quaternary care center after initial work-up and diagnosis, evaluation of both groups will be useful to maximize the number of participants evaluated and to provide a representative sample of patients typically treated. During the study, participants will ultimately be deemed to have;

  1. A specific clinical and pathologic subtype of PACNS,
  2. PACNS not otherwise specified (NOS) without pathologic or clinical proof of a specific subtype, or
  3. An alternative diagnosis other than PACNS.

Patients will undergo a standardized imaging and clinical examination at presentation and at pre-defined follow-up periods. Imaging examinations will include an MRI of the head, standard magnetic resonance angiogram (MRA) of the head, and intracranial vessel wall imaging without and with IV gadolinium. Patients will receive up to 4 imaging examinations at predefined intervals as part of this study. MRI/MRA/Vessel wall features will be evaluated by 2 neuroradiologists. Imaging findings will be correlated to clinical and any available laboratory or pathologic data. The target accrual is 10 patients for this pilot study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with suspected primary CNS vasculitis.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Intracranial Vessel Wall Imaging for Suspected CNS Vasculitis Diagnosis and Assessment of Disease Activity.
Actual Study Start Date : July 24, 2017
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : June 24, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Suspected CNS Vasculitis
Patients with suspected CNS vasculitis will undergo an MRI, including intracranial vessel wall imaging.
Device: MRI, including intracranial vessel wall imaging
MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)

Primary Outcome Measures :
  1. Number of Subjects with Diagnosis of Stroke [ Time Frame: Approximately 5 months after baseline ]
    Clinical or MRI evidence of stroke on follow-up exam.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient is determined to have suspected PACNS upon evaluation by a neurologist or rheumatologist or may have an established diagnosis of PACNS of any duration as determined by a neurologist or rheumatologist.
  2. Ability to undergo routine clinical testing, including lumbar puncture performed for PACNS to exclude potential alternative diagnoses (for initial suspected cases).
  3. Ability to provide informed consent.

Exclusion Criteria:

  1. Less than 18 years of age.
  2. Any absolute contraindication to 3 Tesla MRI.
  3. Any absolute contraindication to gadolinium.
  4. Contraindication to lumbar puncture such as severe coagulopathy.
  5. High risk carotid atherosclerotic plaque defined as either greater than 70% stenosis or known high risk plaque features such as intra-plaque hemorrhage.
  6. Medium or high risk factors for cardioembolic stroke based on the Trial of Org 10172 in Acute Stroke Treatment (TOAST) criteria.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03166319

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Contact: Caleb Hammel 507-293-0925
Contact: Suson M Walsh 507-293-0039 walsh.suson@mayo.du

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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Caleb Hammel    507-293-0925   
Contact: Suson M Walsh    507-293-0039   
Principal Investigator: Vance Lehman, MD         
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Vance Lehman, MD Mayo Clinic

Additional Information:
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Responsible Party: Vance Lehman, Assistant Professor of Radiology, Mayo Clinic, Mayo Clinic Identifier: NCT03166319     History of Changes
Other Study ID Numbers: 16-009297
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Vasculitis, Central Nervous System
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Autoimmune Diseases
Immune System Diseases