Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus
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|ClinicalTrials.gov Identifier: NCT00730002|
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : December 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuropsychiatric Systemic Lupus Erythematosus||Procedure: Magnetic Resonance Angiography (MRA) Procedure: Magnetic resonance imaging Procedure: MRA Procedure: diffusion Imaging Procedure: perfusion imaging.||Not Applicable|
Purpose of the Study:
We plan with this study to obtain pilot data to support a larger grant application which will evaluate whether any of three types of functional Magnetic Resonance Imaging (known as MR Spectroscopy [MRS], MR Perfusion Imaging, and MR Diffusion Tensor Imaging [DTI]) can detect alterations in brain function distinctive for Neuropsychiatric Systemic Lupus Erythematosus (NPSLE), Systemic Lupus Erythematosus (SLE), and compare our findings to those found in an existing cohort of 20 normal healthy controls. Because this study is being done on a 3T(tesla)scanner (3T(tesla) Achieva(Model name), Philips Medical Systems) and our previous group of healthy controls was assessed using a 1.5 T(tesla) scanner (LX EchoSpeed, General Electric(GE) Medical Systems), we propose to re-consent 10 of the previous 20 healthy controls and re-collect imaging data on the 3T(tesla) scanner in order to confirm that our previously-collected data from the group of 20 healthy controls is still valid. This will confirm that the change of field strength and manufacturer does not affect data validity.
Recruiting Update as of March/2009: Enrollment is completed for Study Arms 1 and 2.
This study is only being conducted in Ann Arbor, Michigan. Travel reimbursement does not include hotel accommodations or air fare to and from Ann arbor, Michigan.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Magnetic Resonance Spectroscopy, Perfusion, and Diffusion Tensor Imaging in Neuropsychiatric Lupus|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||December 2014|
Active Comparator: 1- Healthy Subjects
Healthy Subjects- receive MRA
Procedure: Magnetic Resonance Angiography (MRA)
As part of the Magnetic Resonance(MR) scan, you will need to lie still on a padded MR table inside the MR machine for about 15 minutes at a time while MR studies are being performed on you. The total time for the clinical portion of the MR study is approximately 35-40 minutes and there will be an additional 30 minutes for the research related MR studies. The total time you will spend on the MR table for this research will seldom be more than one hour.
Other Name: Magnetic resonance imagingProcedure: Magnetic resonance imaging
Other Name: MRA
Active Comparator: 2 - patients with SLE, no neuropsych
Systemic Lupus Erythematosus(SLE) patients without neuropsychiatric symptoms - receive MRA
Procedure: Magnetic resonance imaging
Other Name: MRAProcedure: MRA
MRA of the brain
Active Comparator: 3 - patients with SLE with neuropsych
20 symptomatic neuropsychiatric systemic lupus erythematosus(NPSLE) patients.
Procedure: diffusion Imaging
MRA of the Brain
Active Comparator: 4- healthy patients from other cohort
10 Healthy Controls (HC) from an existing cohort as part of another sponsored study.
Procedure: perfusion imaging.
MRA of the brain
- This pilot data will be used to strengthen our application for a larger grant to definitively study the sensitivity and specificity of these alterations. [ Time Frame: At 6 month intervals ]
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): NCT00730002
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Pia Maly Sundgren, MD-PHD||University of Michigan|
|Principal Investigator:||Pia Maly Sundgren, MD, PHD||University of Michigan|