- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001591
Functional and Metabolic Imaging Using Magnetic Resonance Imaging and Spectroscopy
Technical advances in magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) have provided researchers with the opportunity to study changes of the central nervous system (CNS) and improve diagnosis and therapy of CNS disease. New MRI and MRS techniques specifically designed for functional MRI (fMRI) and MRS imaging of the CNS will be evaluated in normal volunteers and in patients with CNS diseases. This study will develop and evaluate new magnetic resonance pulse sequences for performing MRI or MRS and compare the results to existing MR techniques.
Patients and volunteers age 18 and older are eligible for the study. A history will be taken in which exclusion criteria (such as having a pacemaker or cochlear implants) will be addressed, and a pregnancy test will be administered to women of childbearing age. Each subject will also be asked to fill out a questionnaire.
Study participants will lie in the MRI scanner from 20 minutes to 2 hours. A coil may be placed on the head and participants may be asked to do simple or complex tasks. A catheter will be placed in an arm vein and a contrast agent will be administered. This agent will allow structures in the brain to show up more clearly.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- Warren G. Magnuson Clinical Center (CC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Any normal volunteer age 18 and over who is capable of giving informed consent.
For the purposes of evaluating new techniques for fMRI, patients will be considered the same as volunteers.
EXCLUSION CRITERIA:
A subject will be excluded if he/she has a contraindication to MR scanning such as the following: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body or implant (e.g., metal shavings, retinal clips); breast implants or Insulin pump.
Subjects who have a history of a reaction to MR contrast agents specifically gadopentetate dimeglumine will be excluded from participating in the contrast agent administration part of this protocol. The contraindications to MRI at 1.5 Tesla and 4 Tesla are identical.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Mattay VS, Frank JA, Santha AK, Pekar JJ, Duyn JH, McLaughlin AC, Weinberger DR. Whole-brain functional mapping with isotropic MR imaging. Radiology. 1996 Nov;201(2):399-404. doi: 10.1148/radiology.201.2.8888231.
- Duyn JH, Yang Y, Frank JA, Mattay VS, Hou L. Functional magnetic resonance neuroimaging data acquisition techniques. Neuroimage. 1996 Dec;4(3 Pt 3):S76-83. doi: 10.1006/nimg.1996.0057.
- Sorensen AG, Tievsky AL, Ostergaard L, Weisskoff RM, Rosen BR. Contrast agents in functional MR imaging. J Magn Reson Imaging. 1997 Jan-Feb;7(1):47-55. doi: 10.1002/jmri.1880070108.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 970152
- 97-CC-0152
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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