Vessel Wall Imaging for Diagnosis and Monitoring of Central Nervous System (CNS) Vasculitis
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|ClinicalTrials.gov Identifier: NCT03166319|
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vasculitis, CNS Vasculitis, Cerebral||Device: MRI, including intracranial vessel wall imaging||Not Applicable|
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;
- A specific clinical and pathologic subtype of PACNS,
- PACNS not otherwise specified (NOS) without pathologic or clinical proof of a specific subtype, or
- 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 (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with suspected primary CNS vasculitis.|
|Masking:||None (Open Label)|
|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|
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)
- Number of Subjects with Diagnosis of Stroke [ Time Frame: Approximately 5 months after baseline ]Clinical or MRI evidence of stroke on follow-up exam.
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 ClinicalTrials.gov identifier (NCT number): NCT03166319
|Contact: Caleb Hammelemail@example.com|
|Contact: Suson M Walshfirstname.lastname@example.org|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55902|
|Contact: Caleb Hammel 507-293-0925 email@example.com|
|Contact: Suson M Walsh 507-293-0039 firstname.lastname@example.org|
|Principal Investigator: Vance Lehman, MD|
|Principal Investigator:||Vance Lehman, MD||Mayo Clinic|