HealthyNCT00611013
Magnetic Resonance Imaging and Spectroscopy at High Field
A study testing Magnetic Resonance Imaging in people with Healthy, run by University of California, Irvine at 1 site in United States.
Trial summary
Evaluating novel MR imaging techniques on volunteers. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Jul 2012
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy normal volunteers for imaging protocol optimization.
Who cannot join
- Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
- Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
- Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported),
- Patients with compromised thermoregulatory systems (e.g. certain cancer patients),
- Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
- Patients with implanted prosthetic heart valves,
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- Patients with pacemakers, neuro-stimulation devices,
- Pregnant patients (the safety of magnetic resonance examination has not been completely established for embryos and fetuses),
- Subjects who have received orthodontic work involving ferromagnetic materials,
- Subjects who have claustrophobia, and
- The patients unwilling to participate in the study or fail to sign the consent form.
- Subjects who are pregnant or breast-feeding will be excluded from the contrast enhanced MRI studies.
- Subjects who had allergic response to contrast agents previously will be excluded from contrast enhanced MRI studies.
- Subjects with known history of asthma, allergic conditions, severe renal insufficiency, sickle cell anemia, chronic hemolytic anemia, gastrointestinal disorders will also be excluded from contrast enhanced MRI studies.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Functional Onco-Imaging, University of California
Irvine, California, 92697
About this study
Evaluating novel MR imaging techniques on volunteers.
Read the detailed description
The aim of this study is twofold. The first aim is to evaluate new MRI techniques developed by the investigators of this protocol on human volunteers. The second aim is to assist other investigators who need to use MR images obtained on this device for their own research. MR images and/or spectroscopy data will be acquired from the participants in this protocol.
- Conditions
- Healthy
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Development of multi-purpose novel imaging protocols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Some participants may receive MRI contrast agent, 0.1 mmol/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startJun 2002
- Primary completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Ying (Lydia) Su, University of California, Irvine
- Investigators
- Lutfi T Muftuler, Ph.D., Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611013
- Sponsor's protocol ID
- UCI-HS-2002-2611
- Status last verified
- Jun 2013
- First submitted
- 12 Jan 2008
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging and Spectroscopy at High Field
- ClinicalTrials.gov ID
- NCT00611013
- Acronym / sponsor ID
- UCI-HS-2002-2611
- Conditions
- Healthy
- Keywords
- Development of multi-purpose novel imaging protocols
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jul 2012 (estimated)
- First posted
- 8 Feb 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.
Evaluating novel MR imaging techniques on volunteers.
Detailed description
The aim of this study is twofold. The first aim is to evaluate new MRI techniques developed by the investigators of this protocol on human volunteers. The second aim is to assist other investigators who need to use MR images obtained on this device for their own research. MR images and/or spectroscopy data will be acquired from the participants in this protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy normal volunteers for imaging protocol optimization.
Key exclusion criteria (14 listed)
- Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
- Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
- Patients with permanent (tattoo) eye-liner or with facial make-up (severe eye irritation has been reported),
- Patients with compromised thermoregulatory systems (e.g. certain cancer patients),
- Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
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 |
|---|---|---|
| Magnetic Resonance ImagingSome participants may receive MRI contrast agent, 0.1 mmol/kg | Device | – |
Primary outcome
General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
Lutfi T Muftuler, Ph.D. principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Healthy, run by University of California, Irvine 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 14 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: withdrawn, as of the sponsor's last update on 21 Jun 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
General purpose novel magnetic resonance imaging contrasts, developments for improved magnetic resonance image quality (time frame: 10 years). 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 21 Jun 2013.