Hepatocellular CarcinomaNCT01341132
Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
An observational study of Hepatocellular Carcinoma, run by San Francisco Veterans Affairs Medical Center at 1 site in United States.
Trial summary
This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MRI Scan of the Liver enhanced with Eovist
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 75 patients of the San Francisco VA Medical Center with suspected HCC identified on contrast-enhanced multi-detector CT, or on ultrasound and referred to contrast-enhanced multi-detector CT.
Who may be able to join
- Alpha-feto protein > 400 ng / mL or
- prior ultrasound with mass suspicious for hepatic malignancy or.
- clinical risk of hepatocellular carcinoma or
- prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma
Who cannot join
- Glomerulo-filtration rate < 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study
- Previous diagnosis of hepatic malignancy
- Any conditions that would discount the ability to have an MRI scan
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco VA Medical Center
San Francisco, California, 94121
About this study
This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MRI Scan of the Liver enhanced with Eovist
- Keywords
- HCC, Hepatocellular Carcinoma, MRI, Liver
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI Scan of the Liver enhanced with EovistProcedure or surgery
10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total
| Study group | Role | What they receive |
|---|---|---|
| Suspected Liver Disease | 1. Alpha-feto protein > 400 ng / mL or
2. prior ultrasound with mass suspicious for hepatic malignancy or.
3. clinical risk of hepatocellular carcinoma or
4. prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma Receives: Procedure: MRI Scan of the Liver enhanced with Eovist |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Francisco Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, University of California, San Francisco
- Investigators
- Rizwan Aslam, MD, Principal investigator, San Francisco VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341132
- Sponsor's protocol ID
- 10-03278
- Status last verified
- Apr 2011
- First submitted
- 21 Apr 2011
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cirrhosis and Malignant Hepatic Lesions Using Novel MR Contrast Agents
- ClinicalTrials.gov ID
- NCT01341132
- Acronym / sponsor ID
- 10-03278
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, Hepatocellular Carcinoma, MRI, Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- San Francisco Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, University of California, San Francisco
- Study start
- May 2011
- Primary completion
- Jun 2012 (estimated)
- First posted
- 25 Apr 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.
This study aims to determine whether or not gadoxetate disodium (Eovist) enhanced magnetic resonance imaging (MRI) has a higher sensitivity for detecting hepatocellular carcinoma (Liver Cancer) comparison to multi-detector computed tomography (CT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Liver Disease | – | Procedure: MRI Scan of the Liver enhanced with Eovist1. Alpha-feto protein > 400 ng / mL or 2. prior ultrasound with mass suspicious for hepatic malignancy or. 3. clinical risk of hepatocellular carcinoma or 4. prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 75 patients of the San Francisco VA Medical Center with suspected HCC identified on contrast-enhanced multi-detector CT, or on ultrasound and referred to contrast-enhanced multi-detector CT.
Key inclusion criteria (4 listed)
- Alpha-feto protein > 400 ng / mL or
- prior ultrasound with mass suspicious for hepatic malignancy or.
- clinical risk of hepatocellular carcinoma or
- prior multi-detector CT with mass suspicious for possible hepatocellular carcinoma
Key exclusion criteria (3 listed)
- Glomerulo-filtration rate < 50 mL/ min/1.73 m2 based on a creatinine measurement within three months of the MR study
- Previous diagnosis of hepatic malignancy
- Any conditions that would discount the ability to have an MRI scan
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 Scan of the Liver enhanced with Eovist10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total | Procedure or surgery | Suspected Liver Disease |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
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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.
Rizwan Aslam, MD principal investigator
San Francisco VA Medical Center
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 Hepatocellular Carcinoma, run by San Francisco Veterans Affairs Medical Center 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: status not confirmed, as of the sponsor's last update on 25 Apr 2011. 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?
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.
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 25 Apr 2011.