HealthyNCT00056914
Development of Techniques for Use in MRI With a Magnetic Field of 7 Tesla
An observational study of Healthy and Magnetic Resonance Imaging, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Magnetic Resonance Imaging
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2003to 5 Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Only neurologically and psychiatrically normal, male or female, healthy volunteers over 18 years old will be used in these studies. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document.
Who cannot join
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings or insulin pump), dental work such as crowns or bridges with indeterminate metals, pre-existing eye conditions, and any pre-existing hearing problems. Subjects who underwent brain surgery, who have a neurological lesion, a psychiatric history or a history of migraine will also be excluded from this study. The contraindications for MRI at 7T are identical to those at 1.5T and 3T.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
...
Read the detailed description
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.
- Conditions
- Healthy, Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Functional Imaging, Cerebral Blood Flow, Parallel Imaging, BOLD Effect, Spectroscopic Imaging, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2003 (estimated)
- Study start21 Mar 2003
- Study completion5 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056914
- Sponsor's protocol ID
- 030142
- Other IDs
- 03-N-0142
- Status last verified
- 5 Jan 2010
- First submitted
- 26 Mar 2003
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Robitaille PM, Abduljalil AM, Kangarlu A, Zhang X, Yu Y, Burgess R, Bair S, Noa P, Yang L, Zhu H, Palmer B, Jiang Z, Chakeres DM, Spigos D. Human magnetic resonance imaging at 8 T. NMR Biomed. 1998 Oct;11(6):263-5. doi: 10.1002/(sici)1099-1492(199810)11:63.0.co;2-0.
PubMed 9802467Abduljalil AM, Kangarlu A, Zhang X, Burgess RE, Robitaille PM. Acquisition of human multislice MR images at 8 Tesla. J Comput Assist Tomogr. 1999 May-Jun;23(3):335-40. doi: 10.1097/00004728-199905000-00001.
PubMed 10348433Burgess RE, Yu Y, Abduljalil AM, Kangarlu A, Robitaille PM. High signal-to-noise FLASH imaging at 8 Tesla. Magn Reson Imaging. 1999 Oct;17(8):1099-103. doi: 10.1016/s0730-725x(99)00072-7.
PubMed 10499671
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of 7 Tesla MRI Methodology for Anatomical Functional and Spectroscopic Imaging of the Brain
- ClinicalTrials.gov ID
- NCT00056914
- Acronym / sponsor ID
- 030142
- Conditions
- Healthy, Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Functional Imaging, Cerebral Blood Flow, Parallel Imaging, BOLD Effect, Spectroscopic Imaging, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 21 Mar 2003
- Study completion
- 5 Jan 2010
- First posted
- 26 Mar 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
Detailed description
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Only neurologically and psychiatrically normal, male or female, healthy volunteers over 18 years old will be used in these studies. Subjects must be capable of understanding the procedures and requirements of this study. Subjects must be willing to sign an informed consent document.
Key exclusion criteria (1 listed)
- A subject will be excluded if he/she has a contraindication to MR scanning such as the following: pregnancy, aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or auto-defibrillator; cochlear implant; ocular foreign body (e.g. metal shavings or insulin pump), dental work such as crowns or bridges with indeterminate metals, pre-existing eye conditions, and any pre-existing hearing problems. Subjects who underwent brain surgery, who have a neurological lesion, a psychiatric history or a history of migraine will also be excluded from this study. The contraindications for MRI at 7T are identical to those at 1.5T and 3T.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 9802467Robitaille PM, Abduljalil AM, Kangarlu A, Zhang X, Yu Y, Burgess R, Bair S, Noa P, Yang L, Zhu H, Palmer B, Jiang Z, Chakeres DM, Spigos D. Human magnetic resonance imaging at 8 T. NMR Biomed. 1998 Oct;11(6):263-5. doi: 10.1002/(sici)1099-1492(199810)11:63.0.co;2-0.
- Background: PubMed 10348433Abduljalil AM, Kangarlu A, Zhang X, Burgess RE, Robitaille PM. Acquisition of human multislice MR images at 8 Tesla. J Comput Assist Tomogr. 1999 May-Jun;23(3):335-40. doi: 10.1097/00004728-199905000-00001.
- Background: PubMed 10499671Burgess RE, Yu Y, Abduljalil AM, Kangarlu A, Robitaille PM. High signal-to-noise FLASH imaging at 8 Tesla. Magn Reson Imaging. 1999 Oct;17(8):1099-103. doi: 10.1016/s0730-725x(99)00072-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Magnetic Resonance Imaging, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056914, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.