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

The Utility of Intracranial Vessel Wall Imaging for Suspected CNS Vasculitis Diagnosis and Assessment of Disease Activity.

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.

Study Overview

• Status: Completed
• Conditions: Vasculitis, CNS; Vasculitis, Cerebral
• Intervention / Treatment: Diagnostic test: MRI, including intracranial vessel wall imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Suspected CNS Vasculitis; Patients with suspected CNS vasculitis will undergo an MRI, including intracranial vessel wall imaging.	Diagnostic test: MRI, including intracranial vessel wall imaging; MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Diagnosis of Stroke	Clinical or MRI evidence of stroke on follow-up exam.	Approximately 5 months after baseline

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Vance Lehman, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2017
• Primary Completion (Actual): November 24, 2020
• Study Completion (Actual): November 24, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Vasculitis; Vasculitis, Central Nervous System
• Other Study ID Numbers: 16-009297

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No