Hepatocellular CarcinomaNCT02156739
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
A study testing Contrast-enhanced Magnetic Resonance Imaging, Gadobutrol and Gadoxetate Disodium in people with Hepatocellular Carcinoma and Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver
- What is being tested?
- Contrast-enhanced Magnetic Resonance Imaging, Gadobutrol and Gadoxetate Disodium
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2014to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
- Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)
- Any disease type
Who cannot join
- Pregnant women
- Patients with impaired renal function (eGFR < 30)
- Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
- Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.
OUTLINE:
Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.
- Conditions
- Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
- Being tested
- Contrast-enhanced Magnetic Resonance Imaging, Gadobutrol, Gadoxetate Disodium
- Medical subject headings
- Carcinoma, Hepatocellular, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced Magnetic Resonance ImagingProcedure or surgery
Also called CONTRAST ENHANCED MRI, Contrast-enhanced MRI
Undergo contrast-enhanced MRI
GadobutrolDrug
Also called BAY86-4875, Gadavist, Gadograf, Gadovist
Given IV
Gadoxetate DisodiumDrug
Also called Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid Disodium
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (contrast-enhanced MRI) | Experimental | Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately. Receives: Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Gadobutrol; Drug: Gadoxetate Disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study start13 Oct 2014
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (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.
- More trials run by M.D. Anderson Cancer CenterThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Janio Szklaruk, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156739
- Sponsor's protocol ID
- 2012-1157
- Other IDs
- NCI-2014-02333, 2012-1157
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2014
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
- ClinicalTrials.gov ID
- NCT02156739
- Acronym / sponsor ID
- 2012-1157
- Conditions
- Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Jun 2014 (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 clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
Detailed description
PRIMARY OBJECTIVES:
- To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.
OUTLINE:
Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (contrast-enhanced MRI) | Experimental | Procedure: Contrast-enhanced Magnetic Resonance Imaging, Drug: Gadobutrol, Drug: Gadoxetate DisodiumPatient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
- Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)
- Any disease type
Key exclusion criteria (4 listed)
- Pregnant women
- Patients with impaired renal function (eGFR < 30)
- Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
- Patients with contraindications to the use of intravenous contrast such as allergic type reactions
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 |
|---|---|---|
| Contrast-enhanced Magnetic Resonance ImagingAlso: CONTRAST ENHANCED MRI, Contrast-enhanced MRIUndergo contrast-enhanced MRI | Procedure or surgery | Diagnostic (contrast-enhanced MRI) |
| GadobutrolAlso: BAY86-4875, Gadavist, Gadograf, GadovistGiven IV | Drug | Diagnostic (contrast-enhanced MRI) |
| Gadoxetate DisodiumAlso: Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid DisodiumGiven IV | Drug | Diagnostic (contrast-enhanced MRI) |
Primary outcome
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
Time frame: Up to 4 years
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Janio Szklaruk, MD, PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced Magnetic Resonance Imaging, Gadobutrol and Gadoxetate Disodium in people with Hepatocellular Carcinoma and Liver and Intrahepatic Bile Duct Disorder, run by M.D. Anderson Cancer 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI) (time frame: Up to 4 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 23 Jun 2026.