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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03166319
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Vance Lehman, MD
Principal Investigator Affiliation	Mayo Clinic
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Vasculitis, CNS, Vasculitis, Cerebral
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Suspected CNS Vasculitis

Patients with suspected CNS vasculitis will undergo an MRI, including intracranial vessel wall imaging.

Interventions

Device: - MRI, including intracranial vessel wall imaging

MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55902

Site Contact

Caleb Hammel

[email protected]

507-293-0925

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