HealthyNCT00738712
Refinement and Assessment of New Magnetic Resonance Imaging (MRI) Technologies for Vascular, Abdominal, and Pelvic Exams
A study testing MRI Magnetic Resonance Imaging in people with Healthy, 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 designed to improve MRI examinations of the vascular structures, abdomen, and pelvis regions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- MRI Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2011to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or non-pregnant female patient
- 18 years or older
- any ethnic background
- presenting to MRI for a clinically-ordered chest 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 Center
Ann Arbor, Michigan, 48109
About this study
This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies designed to improve MRI examinations of the vascular structures, abdomen, and pelvis 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 vascular structures, abdomen, and pelvis regions. Software and hardware are always being improved, new machines replace old machines, software is updated and improved as well as devices used to produce better MRI images.
- Conditions
- Healthy
- Being tested
- MRI Magnetic Resonance Imaging
- Keywords
- Vascular MRI, Abdominal MRI, Pelvic MRI, Breast MRI, Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance Imaging
MRI
| Study group | Role | What they receive |
|---|---|---|
| New MRI techniques | Experimental | New hardware or software technologies designed to improve MRI (Magnetic Resonance Imaging) exams. Receives: Procedure: MRI Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of new software in MRI vascular imaging
New software technology will be utilized to enhance MRI imaging of the vascular regions of the body.
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 posted20 Aug 2008 (estimated)
- Study start2 May 2011
- 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 HealthyStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- General Electric, Philips Healthcare
- Responsible party
- Principal investigator, William Masch, University of Michigan
- Investigators
- William Masch, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738712
- Sponsor's protocol ID
- HUM00041815
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2008
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 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 for Vascular, Abdominal, and Pelvic Exams
- ClinicalTrials.gov ID
- NCT00738712
- Acronym / sponsor ID
- HUM00041815
- Conditions
- Healthy
- Keywords
- Vascular MRI, Abdominal MRI, Pelvic MRI, Breast MRI, Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- General Electric, Philips Healthcare
- Study start
- 2 May 2011 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 20 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 designed to improve MRI examinations of the vascular structures, abdomen, and pelvis 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 vascular structures, abdomen, and pelvis regions. Software and hardware are always being improved, new machines replace old machines, software is updated and improved as well as 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 |
|---|---|---|
| New MRI techniques | Experimental | Procedure: MRI Magnetic Resonance ImagingNew hardware or software technologies designed to improve MRI (Magnetic Resonance Imaging) exams. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or non-pregnant female patient
- 18 years or older
- any ethnic background
- presenting to MRI for a clinically-ordered chest 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 |
|---|---|---|
| MRI Magnetic Resonance ImagingAlso: Magnetic Resonance ImagingMRI | Procedure or surgery | New MRI techniques |
Primary outcome
Evaluation of new software in MRI vascular imaging
Time frame: 1 year
New software technology will be utilized to enhance MRI imaging of the vascular regions of the body.
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 13 Jan 2021.
- Individual participant dataSharing planned: No
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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.
William Masch, 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 Magnetic Resonance Imaging in people with Healthy, 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 4 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 13 Jan 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?
Evaluation of new software in MRI vascular imaging (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 13 Jan 2021.