The CAVS-MS study seeks to answer whether the Central Vein Sign can be used as a sensitive and specific diagnostic marker for a diagnosis of MS. The study will investigate the Central Vein Sign using MRI in a mixed population of participants presenting for a suspected diagnosis of MS with typical clinical presentations and atypical presentations including radiological presentations without neurological symptoms.
We will follow study participants for up to 24 months to determine the specificity and sensitivity of the Central Vein Sig for a diagnosis of MS using the 2017 McDonald Criteria.
Inclusion Criteria
- Age 18 to 65 inclusive
- Referral to a study academic site for a clinical suspicion of MS
- Onset with typical or atypical presentations of MS
- Able to provide written informed consent to participate in the study
- For participants referred for clinical suspicion of multiple sclerosis who had workup prior to referral or who are taking disease-modifying therapies for MS, digital availability of diagnostic cranial MRI with gadolinium within 3 months of initial symptoms
- Onset of typical neurological symptoms within 10 years of screening.
Exclusion Criteria
- Contraindication to MRI studies; metal or metal implants incompatible with MRI
- Inability to tolerate MRI due to claustrophobia or known excessive movement (e.g.tremor)
- Contraindication to use of gadolinium containing contrast agents (allergy or renal failure)
- Treatment with systemic corticosteroids in the 4 weeks preceding enrollment
Clinical trial information
https://www.clinicaltrials.gov/ct2/show/NCT04495556
IRB Study Number 17-976
Status Not yet recruiting
CAVS-MS at the University of Texas at Austin
Location: UT Health Austin, MS and Neuroimmunology Center
Dell Seton Medical Center
Local site principal investigator: Leorah Freeman, MD, PhD
Research coordinators: Sarah Campbell, RN; Helen Onuorah, BA
Contact: ms.io@austin.utexas.edu
Sponsor
The Cleveland Clinic
Principal Investigators: Dan Ontaneda, MD, The Cleveland Clinic
Nancy Sicotte, MD, Cedars-Sinai Medical Center
Contact: Praneeta C Raza, MD, MSc 216-445-9692 razap@ccf.org
