Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy
ASL sequences have been shown to localize certain epileptogenic abnormalities such as tubers in tuberous sclerosis. A previous study demonstrated ASL changes inter- and post-ictally in one patient without other MRI changes. This is a promising technique that has not been fully evaluated as of yet. Of note, all studies done in this area in regards to epilepsy have been retrospective, small studies. The investigators plan to perform a study that is prospective, with a comparatively large sample of patients.
The study hypothesis is that in patients with refractory epilepsy, Arterial Spin Labeling (ASL) MRI will show areas of abnormality in the brain to the same degree as SPECT and PET studies.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Arterial Spin Labeling MRI Focal Abnormalities in Refractory Epilepsy|
- Imaging abnormalities on ASL MRI that correlate with PET and SPECT. [ Time Frame: 1-2 years ] [ Designated as safety issue: No ]correlation of ASL MRI abnormalities to PET and SPECT study abnormalities within the same patient.
- quantitative cerebral blood perfusion [ Time Frame: 2 months ] [ Designated as safety issue: No ]Determine quantitative cerebral blood perfusion changes in lesions detected by ASL MRI
|Study Start Date:||January 2013|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Arterial spin labeled (ASL) MRI sequence
Patients will have a standard epilepsy protocol (Mayo Clinic) MRI with additional ASL sequence performed during that MRI (Arterial spin labeled (ASL) MRI sequence).
Device: Arterial spin labeled (ASL) MRI sequence
The arterial spin labeled MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence.
Currently, in presurgical evaluation of epilepsy patients, PET and SPECT studies are utilized to evaluate metabolic and perfusion abnormalities respectively to localize seizure onset. This is especially true in "MRI negative" patients, whose lesion is not visible on standard MRI techniques. PET and SPECT studies have numerous disadvantages, including radiation exposure, injection of contrast or isotopes, cost, and are often difficult to access for many patients.
Arterial spin labeling (ASL) MRI sequences show perfusion related abnormalities without using contrast, in a relatively short amount of time, and can be done during a normal MRI for evaluation of epilepsy. This is of interest because if there is a good correlation, ASL MRI sequences could be used in addition, or in place of, these other studies that require injection of isotopes and radiation from CT scans.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772654
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Cheolsu Shin, MD||Mayo Clinic|