Nervous System DiseasesNCT00739518
Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams
A study testing MRI in people with Nervous System Diseases, run by University of Michigan at 1 site in United States.
Trial summary
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to 14 Jan 2020
- Phase
- Interventional
- 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
- If you are a male or a non-pregnant female patient
- Normal volunteer
- presenting to MRI for a clinically-ordered neurological or head and neck MRI exam
Who cannot join
- Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
- Pregnant patients or patients who are lactating.
- A patient who is claustrophobic
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
Official title: Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.
Read the detailed description
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head \& neck regions.
Software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.
- Conditions
- Nervous System Diseases
- Being tested
- MRI
- Keywords
- Neurological, MRI
- Medical subject headings
- Nervous System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Neurological MRI with new technology evaluation. The new technology may involve software or MRI scanning sequences. This is a long term research study that focuses on new technology that is constantly being created.
| Study group | Role | What they receive |
|---|---|---|
| MRI scan - new technology | Experimental | The patient's clinical MRI scan will also utilize some new technology, such as a change in software or additional MRI sequences Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in quality of MRI studies in Neuroradiology
Specific Measurement Are:
- Scan speed - is the new method as fast or faster than regular method(s)
- Signal to noise - Subjectively, or quantitatively do we get the same, better, or new contrast compared to the regular methods(s).
- Image contrast - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).
- Spatial resolution - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s).
- Artifact - Subjectively, or quantitatively do we get the better artifact reduction compared to the regular method(s).
- Ergonomics - Is the new software easier to work or offer more information more cleanly than the regular software
- Patient comfort - Subjectively, does the new software and/or hardware make the patient's MRI experience more comfortable.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2008 (estimated)
- Study startOct 2004
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric, Philips Medical Systems
- Responsible party
- Principal investigator, Ashok Srinivasan, M.D., University of Michigan
- Investigators
- Ashok Srivinasan, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739518
- Sponsor's protocol ID
- HUM00041731
- Status last verified
- Mar 2021
- First submitted
- 20 Aug 2008
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies
- ClinicalTrials.gov ID
- NCT00739518
- Acronym / sponsor ID
- HUM00041731
- Conditions
- Nervous System Diseases
- Keywords
- Neurological, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- General Electric, Philips Medical Systems
- Study start
- Oct 2004 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 21 Aug 2008 (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 is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.
Detailed description
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head \& neck regions.
Software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scan - new technology | Experimental | Procedure: MRIThe patient's clinical MRI scan will also utilize some new technology, such as a change in software or additional MRI sequences |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- If you are a male or a non-pregnant female patient
- Normal volunteer
- presenting to MRI for a clinically-ordered neurological or head and neck MRI exam
Key exclusion criteria (3 listed)
- Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
- Pregnant patients or patients who are lactating.
- A patient who is claustrophobic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRINeurological MRI with new technology evaluation. The new technology may involve software or MRI scanning sequences. This is a long term research study that focuses on new technology that is constantly being created. | Procedure or surgery | MRI scan - new technology |
Primary outcome
Improvement in quality of MRI studies in Neuroradiology
Time frame: 1 year
Specific Measurement Are: 1. Scan speed - is the new method as fast or faster than regular method(s) 2. Signal to noise - Subjectively, or quantitatively do we get the same, better, or new contrast compared to the regular methods(s). 3. Image contrast - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s). 4. Spatial resolution - Subjectively, or quantitatively do we get the same or better resolution compared to the regular method(s). 5. Artifact - Subjectively, or quantitatively do we get the better artifact reduction compared to the regular method(s). 6. Ergonomics - Is the new software easier to work or offer more information more cleanly than the regular software 7. Patient comfort - Subjectively, does the new software and/or hardware make the patient's MRI experience more comfortable.
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 15 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Nervous System Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
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.
Ashok Srivinasan, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Nervous System Diseases, run by University of Michigan 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 3 inclusion and 3 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 15 Mar 2021. 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.
What does the primary outcome measure?
Improvement in quality of MRI studies in Neuroradiology (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2021.