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

Vasculitis, Cerebral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166319
• Other study ID #: 16-009297
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: November 24, 2020

Study information

• Verified date: March 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 24, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vasculitis
• Vasculitis, Central Nervous System
• Vasculitis, Cerebral
• Vasculitis, CNS

Intervention

Diagnostic Test:
• MRI, including intracranial vessel wall imaging
MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Diagnosis of Stroke	Clinical or MRI evidence of stroke on follow-up exam.	Approximately 5 months after baseline

External Links

•   Mayo Clinic Clinical Trials