Hepatocellular CarcinomaNCT01215838
MRI of the Liver With Eovist
An observational study of Hepatocellular Carcinoma, run by University of Washington.
Trial summary
The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jan 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: Patients with known hepatocellular carcinoma undergoing MRI of the liver in the UWMC Radiology Clinic.
Who may be able to join
- known hepatocellular carcinoma
- undergoing MRI of the liver
Who cannot join
- Contraindication to MRI with IV contrast
About this study
Official title: Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.
Read the detailed description
Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.
This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, hepatocellular carcinoma, Eovist, MR, MRI, magnetic resonance
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a new MR protocol in diagnosing HCC and other liver lesions.
Measured: One day: participants will have one MRI of the liver.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011
- Study completionJan 2012
Why it stopped: Unable to meet enrollment expectations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Responsible party
- Sponsor
- Investigators
- Orpheus Kolokythas, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215838
- Sponsor's protocol ID
- DI-2009-1
- Other IDs
- 7160
- Status last verified
- Oct 2013
- First submitted
- 28 Sep 2010
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
PubMed 16514137Saito K, Kotake F, Ito N, Ozuki T, Mikami R, Abe K, Shimazaki Y. Gd-EOB-DTPA enhanced MRI for hepatocellular carcinoma: quantitative evaluation of tumor enhancement in hepatobiliary phase. Magn Reson Med Sci. 2005;4(1):1-9. doi: 10.2463/mrms.4.1.
PubMed 16127248Frericks BB, Loddenkemper C, Huppertz A, Valdeig S, Stroux A, Seja M, Wolf KJ, Albrecht T. Qualitative and quantitative evaluation of hepatocellular carcinoma and cirrhotic liver enhancement using Gd-EOB-DTPA. AJR Am J Roentgenol. 2009 Oct;193(4):1053-60. doi: 10.2214/AJR.08.1946.
PubMed 19770329
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Evaluation of the Liver Using Gadoxetate Disodium (Eovist®) for Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT01215838
- Acronym / sponsor ID
- DI-2009-1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- HCC, hepatocellular carcinoma, Eovist, MR, MRI, magnetic resonance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment expectations.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Oct 2010 (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 is to determine if a new magnetic resonance (MR) protocol is better at diagnosing liver lesions.
Detailed description
Hepatocellular carcinoma (HCC), a form of liver cancer, is the seventh most common cause of cancer mortality in the US. The incidence rate of HCC is increasing along with the incidence of Hepatitis B and C which are known to promote HCC. Patients have a better prognosis (survival outlook) if HCC is found and treated at an early stage. MRI is the best imaging modality for diagnosing HCC.
This study will compare standard MRIs and MRIs performed with a newly developed MR protocol to determine if it is possible to more confidently diagnose HCC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known hepatocellular carcinoma undergoing MRI of the liver in the UWMC Radiology Clinic.
Key inclusion criteria (2 listed)
- known hepatocellular carcinoma
- undergoing MRI of the liver
Key exclusion criteria (1 listed)
- Contraindication to MRI with IV contrast
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
Accuracy of a new MR protocol in diagnosing HCC and other liver lesions.
Time frame: One day: participants will have one MRI of the liver.
Results and safety
The study was stopped early (reason given: Unable to meet enrollment expectations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2013.
- Background: PubMed 16514137Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106.
- Background: PubMed 16127248Saito K, Kotake F, Ito N, Ozuki T, Mikami R, Abe K, Shimazaki Y. Gd-EOB-DTPA enhanced MRI for hepatocellular carcinoma: quantitative evaluation of tumor enhancement in hepatobiliary phase. Magn Reson Med Sci. 2005;4(1):1-9. doi: 10.2463/mrms.4.1.
- Background: PubMed 19770329Frericks BB, Loddenkemper C, Huppertz A, Valdeig S, Stroux A, Seja M, Wolf KJ, Albrecht T. Qualitative and quantitative evaluation of hepatocellular carcinoma and cirrhotic liver enhancement using Gd-EOB-DTPA. AJR Am J Roentgenol. 2009 Oct;193(4):1053-60. doi: 10.2214/AJR.08.1946.
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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.
Orpheus Kolokythas, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by University of Washington.
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 2 inclusion and 1 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 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
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: Unable to meet enrollment expectations.). 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?
Accuracy of a new MR protocol in diagnosing HCC and other liver lesions. (time frame: One day: participants will have one MRI of the liver.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215838, which also lists 3 linked publications.
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 Oct 2013.