Healthy Clinical Trial
Official title:
Development of 7 Tesla MRI Methodology for Anatomical Functional and Spectroscopic Imaging of the Brain
This study will develop new techniques for optimizing resolution in magnetic resonance
imaging (MRI) with a high magnetic field of 7 Tesla. MRI is a diagnostic tool that generates
high-quality images of the body without the use of x-rays. It can also provide information
about brain chemistry and physiology. The test is routinely done at magnetic field strengths
of from 1.5 to 4 Tesla. This study will use an investigational device that operates at a high
magnetic field of 7 Tesla. Except for the increase in magnetic field, all other aspects of
imaging are the same as those at lower magnetic fields. This study will use techniques in
conjunction with the higher magnetic field that may improve diagnostic imaging. The MRI will
monitor the brain at high resolution to see structural features, to measure brain chemicals,
and to determine how much and how fast blood flows into brain regions in response to simple
tasks.
Healthy normal volunteers 18 years of age and older may participate in this study. Candidates
will be screened with a medical history, neurological examination, and questionnaire.
Participants will have a standard 1.5 or 3 Tesla MRI before the 7 Tesla scan, adding about 5
minutes to the procedure. The procedure for both scans is the same. The subject lies on a
table that is moved into the scanner. Because the machine makes loud sounds during the
imaging, earplugs are provided to help reduce the noise. An insulated wire coil may be placed
around the subject's head to obtain better images. Scanning time varies from 20 minutes to 3
hours, with most examinations lasting between 45 and 90 minutes. During the scan, the subject
may be asked to perform simple tasks, such as listening to tones, tapping fingers, moving a
hand, watching a movie on a screen, or smelling pleasant odors. More complex tasks may
require thinking about tones or pictures and responding to them by pressing buttons.
Following the test, subjects will complete a brief questionnaire about comfort level and any
unusual sensations they may have experienced during the test.
Participants who undergo repeated MRIs for the evaluation of new techniques will have a
standard 1.5 or 3 Tesla MRI brain study once a year while participating in the research
protocol. A radiologist at NIH will read the MRIs, and if any abnormalities are discovered,
the individual will be referred to his or her private physician or to a consult service at
NIH.
The goal of this protocol is to optimize new technology that enables Magnetic Resonance
Imaging (MRI) at a static magnetic field strength of 7 Tesla (7T). Techniques will be
developed for anatomical, functional, and spectroscopic MRI that can take advantage of this
high field. Routine clinical MRI has been performed at 1.5T for over twenty years and over
the past ten years MRI at 3-4T has demonstrated large increases in sensitivity and is
beginning to find widespread application for functional imaging of the brain and clinical
research. Since the late 1990's it has been possible to produce magnets with field strengths
between 7-9T large enough for human use. Indeed there are presently two sites with 7T and one
with 8T MRI that have begun to produce exciting images. These initial results confirm that
MRI can be performed safely at these high field strengths and that the whole range of MRI
experiments can be performed. We will take delivery of the first 7T MRI system produced by
General Electric, the leading producer of MRI equipment, sometime in late 2002/early 2003.
Compared to 3-4T, the 7T scanner is expected to improve sensitivity by a factor of two and
improve contrast to noise for functional imaging and spectroscopy by a factor of two - four.
However, realizing these goals for routine practice and whole brain coverage will require
technical developments and integrating these developments into optimized data acquisition and
processing strategies. Therefore, we plan to extend parallel imaging strategies, currently
becoming available for 3T MRI, to 7T in order to realize the full gain in sensitivity and
apply these techniques to obtain high resolution anatomical MRI, generate high temporal and
spatial resolution perfusion images using arterial spin labeling techniques, generate
high-temporal and spatial resolution functional images of the brain using blood oxygenation
(BOLD) and perfusion based techniques, and test the usefulness of 7T for spectroscopic
studies of metabolites of the brain. All of these developments will be performed on normal,
healthy volunteers.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |