Diffuse and Focal Abnormalities of the Liver and PancreasNCT01007357
Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation
A study testing Body MR imaging in people with Diffuse and Focal Abnormalities of the Liver and Pancreas, run by University of Nebraska at 2 sites in United States.
Trial summary
This project will facilitate the optimization of body MR imaging at 3 Tesla. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diffuse and Focal Abnormalities of the Liver and Pancreas
- What is being tested?
- Body MR imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2009to 30 Jun 2015
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects between ages of 19 and 65
- Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history
- Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)
Who cannot join
- Inability to provide informed consent
- A medical or contraindications that will prevent subjects from having a MRI
- Subjects with severe renal dysfunction or patients on dialysis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1045
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This project will facilitate the optimization of body MR imaging at 3 Tesla.
Read the detailed description
This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.
- Being tested
- Body MR imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body MR imagingDevice
Also called Body MR imaging performed to optimize sequences
Body MR imaging will be performed to optimize sequences
| Study group | Role | What they receive |
|---|---|---|
| Body MRI healthy volunteers | Other | Body MRI to optimize sequences in healthy individuals and in disorder subjects Receives: Device: Body MR imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimizing body MR imaging sequences
Healthy volunteers will be used to obtain optimized body MR imaging sequences that will then be used to evaluate MR imaging sequences of subjects with underlying disorders.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study start15 Dec 2009
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Why it stopped: Principal Investigator left institution; did not complete the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse and Focal Abnormalities of the Liver and PancreasStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems
- Responsible party
- Sponsor
- Investigators
- Shahid Hussain, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007357
- Sponsor's protocol ID
- 0290-09-FB
- Status last verified
- Jul 2023
- First submitted
- 28 Oct 2009
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal MR Imaging at 3.0T: Sequence Optimization and Implementation
- ClinicalTrials.gov ID
- NCT01007357
- Acronym / sponsor ID
- 0290-09-FB
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator left institution; did not complete the study
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Philips Medical Systems
- Study start
- 15 Dec 2009 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 4 Nov 2009 (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 project will facilitate the optimization of body MR imaging at 3 Tesla.
Detailed description
This project is meant to improve the image quality of multiple sequences at 3.0T applied to the abdominal and pelvic regions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Body MRI healthy volunteers | Other | Device: Body MR imagingBody MRI to optimize sequences in healthy individuals and in disorder subjects |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects between ages of 19 and 65
- Healthy volunteer subjects should not have any history of disease or symptoms - based on clinical history
- Subjects with an underlying disorder (diffuse and focal abnormalities of the liver and pancreas)
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- A medical or contraindications that will prevent subjects from having a MRI
- Subjects with severe renal dysfunction or patients on dialysis
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 |
|---|---|---|
| Body MR imagingAlso: Body MR imaging performed to optimize sequencesBody MR imaging will be performed to optimize sequences | Device | Body MRI healthy volunteers |
Primary outcome
Optimizing body MR imaging sequences
Time frame: 2 years
Healthy volunteers will be used to obtain optimized body MR imaging sequences that will then be used to evaluate MR imaging sequences of subjects with underlying disorders.
Results and safety
The study was stopped early (reason given: Principal Investigator left institution; did not complete the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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.
Shahid Hussain, MD principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body MR imaging in people with Diffuse and Focal Abnormalities of the Liver and Pancreas, run by University of Nebraska at 2 sites 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: stopped early, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 stopped early (reason given: Principal Investigator left institution; did not complete the study). Results are not available in the source record.
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?
Optimizing body MR imaging sequences (time frame: 2 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 14 Jul 2023.