Underlying Liver DiseaseNCT01390194
Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma
An observational study of Underlying Liver Disease and Hepatitis, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Underlying Liver Disease, Hepatitis, Fibrosis of Liver
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2011to 1 Jun 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with an underlying liver disease
Who may be able to join
- underlying liver disease
- have a lesion on a prior imaging study
- must have prior standard MR
Who cannot join
- Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
- patients with severe kidney dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma: A Pilot Study to Assess the Image Quality (Multitransmit Body MRI Program)
The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.
Read the detailed description
This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.
- Conditions
- Underlying Liver Disease, Hepatitis, Fibrosis of Liver, Cirrhosis With Suspicion of Liver Cancer, Lesion on a Prior Ultrasound, CT or Outside MRI
- Keywords
- liver disease, hepatocellular carcinoma
- Medical subject headings
- Hepatitis, Liver Cirrhosis, Liver Diseases, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| subjects with an underlying liver disease | (1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
image quality outcome
Two MRI exams will be evaluated by two radiologists based on a number of items.
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 posted8 Jul 2011 (estimated)
- Study start1 Jul 2011
- Primary completion1 Jun 2015
- Study completion1 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underlying Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Medical Systems, Bracco Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Shahid Hussain, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390194
- Sponsor's protocol ID
- 0246-10-FB
- Status last verified
- Aug 2023
- First submitted
- 6 Jul 2011
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid 10-Minute Liver MRI Protocol in Patients With Suspected Hepatocellular Carcinoma: A Pilot Study to Assess the Image Quality (Multitransmit Body MRI Program)
- ClinicalTrials.gov ID
- NCT01390194
- Acronym / sponsor ID
- 0246-10-FB
- Conditions
- Underlying Liver Disease, Hepatitis, Fibrosis of Liver, Cirrhosis With Suspicion of Liver Cancer, Lesion on a Prior Ultrasound, CT or Outside MRI
- Keywords
- liver disease, hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Philips Medical Systems, Bracco Diagnostics, Inc
- Study start
- 1 Jul 2011 (actual)
- Primary completion
- 1 Jun 2015 (actual)
- Study completion
- 1 Jun 2015 (actual)
- First posted
- 8 Jul 2011 (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.
The purpose of this study to assess the image quality of the rapid magnetic resonance imaging (MRI) compared to the standard MRI.
Detailed description
This is a pilot study to compare a rapid 10-minute liver magnetic resonance imaging (MRI) protocol to standard MRI in participants with suspected hepatocellular carcinoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with an underlying liver disease | – | –(1)underlying liver disease; (2) have a lesion on a prior imaging study; (3) must be prior standard MR |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with an underlying liver disease
Key inclusion criteria (3 listed)
- underlying liver disease
- have a lesion on a prior imaging study
- must have prior standard MR
Key exclusion criteria (2 listed)
- Contra-indication for MR imaging including pacemaker, claustrophobia, pregnancy, electronic or vascular devices that are contraindicated;
- patients with severe kidney dysfunction
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
image quality outcome
Time frame: 2 years
Two MRI exams will be evaluated by two radiologists based on a number of items.
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 6 Sep 2023.
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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.
Shahid Hussain, MD principal investigator
University of Nebraska
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 Underlying Liver Disease and Hepatitis, run by University of Nebraska 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 2 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 6 Sep 2023. 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?
image quality outcome (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 6 Sep 2023.