Adult Hepatocellular CarcinomaPhase 1NCT02578602
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
A Phase 1 study testing Gadoxetate Disodium and Magnetic Resonance Imaging in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma
- What is being tested?
- Gadoxetate Disodium and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- Phase
- Phase 1
- 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
Who may be able to join
- CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:
- For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2 cm, all of the following criteria must be met:
- Imaging features of a mass
- Wash-out on later phases of contrast administration
- At least 1 cm or more growth
- For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
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- Imaging features of a mass
- Wash-out on later phases of contrast administration
- At least 1 cm or more growth
- All enhancing lesions with expansile, solid, enhancing tumor within vascular structures will be included, including the main portal vein, the main right and main left portal veins, the inferior vena cava (IVC), and the main hepatic veins
- No prior history of treatment of liver lesions
- Able to provide written and verbal informed consent
- Able to tolerate a complete abdominal MR examination, within 3 weeks of CT
Who cannot join
- Unable to provide written and verbal informed consent
- Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
- Pregnancy
- Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
- Severe liver disease as defined by Childs class C cirrhosis
- History of a previous reaction to contrast media
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- History of bronchial asthma
- History of allergic disorders
- Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
This pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the precision of gadoxetate (gadoxetate disodium)-enhanced MRI in evaluating lesion size.
II. To evaluate if there is a subjective improvement in the delineation of hepatocellular carcinoma (HCC) in the hepatocellular phase of contrast administration.
III. To further assess the sensitivity of gadoxetate-enhanced MRI for the detection of HCC.
SECONDARY OBJECTIVES:
- To evaluate the reproducibility of various tumor measurement techniques in the evaluation of HCC.
II. To further evaluate how administration of gadoxetate affects diffusion weighted imaging.
OUTLINE:
Patients receive gadoxetate disodium intravenously (IV) and then undergo enhanced liver MRI.
After completion of study, patients are followed up at 2, 4, 8, and 12 months.
- Conditions
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma, BCLC Stage A Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma
- Being tested
- Gadoxetate Disodium, Magnetic Resonance Imaging
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoxetate DisodiumDrug
Also called Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid Disodium
Given IV
Magnetic Resonance ImagingDevice
Also called Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan
Undergo MRI with gadoxetate disodium
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (gadoxetate disodium MRI) | Experimental | Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI. Receives: Drug: Gadoxetate Disodium; Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
Initially, a random effects analysis of variance (ANOVA) will be performed for each type of image (CT vs. MRI), for each phase (4 for CT and 5 for MRI) and for each method of measuring "size" (1-, 2-, and 3-dimensional) - for a total of 27 ANOVAs. Lesion, radiologist, and replication (for the 20 target lesions measured twice) will all be random effects; the inter-reader and the intra-reader variability will be estimated from these models and 95% confidence intervals will be constructed.
Measured: Up to 24 hours
Secondary outcomes (1)
Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
ADC values will be recorded for uninvolved liver parenchyma and for tumors before and after administration of gadoxetate disodium.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gilbert Whang, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578602
- Sponsor's protocol ID
- 3L-10-1
- Other IDs
- NCI-2014-01850, USC 3L-10-1, HS-10-00188, 3L-10-1, P30CA014089
- Status last verified
- Oct 2015
- First submitted
- 13 Sep 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
- ClinicalTrials.gov ID
- NCT02578602
- Acronym / sponsor ID
- 3L-10-1
- Conditions
- Adult Hepatocellular Carcinoma, Advanced Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma, BCLC Stage A Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Oct 2015 (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 pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the precision of gadoxetate (gadoxetate disodium)-enhanced MRI in evaluating lesion size.
II. To evaluate if there is a subjective improvement in the delineation of hepatocellular carcinoma (HCC) in the hepatocellular phase of contrast administration.
III. To further assess the sensitivity of gadoxetate-enhanced MRI for the detection of HCC.
SECONDARY OBJECTIVES:
- To evaluate the reproducibility of various tumor measurement techniques in the evaluation of HCC.
II. To further evaluate how administration of gadoxetate affects diffusion weighted imaging.
OUTLINE:
Patients receive gadoxetate disodium intravenously (IV) and then undergo enhanced liver MRI.
After completion of study, patients are followed up at 2, 4, 8, and 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (gadoxetate disodium MRI) | Experimental | Drug: Gadoxetate Disodium, Device: Magnetic Resonance ImagingPatients receive gadoxetate disodium IV and then undergo enhanced liver MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:
- No prior history of treatment of liver lesions
- Able to provide written and verbal informed consent
- Able to tolerate a complete abdominal MR examination, within 3 weeks of CT
Key exclusion criteria (9 listed)
- Unable to provide written and verbal informed consent
- Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
- Pregnancy
- Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
- Severe liver disease as defined by Childs class C cirrhosis
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 |
|---|---|---|
| Gadoxetate DisodiumAlso: Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid DisodiumGiven IV | Drug | Diagnostic (gadoxetate disodium MRI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI ScanUndergo MRI with gadoxetate disodium | Device | Diagnostic (gadoxetate disodium MRI) |
Primary outcome
Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
Time frame: Up to 24 hours
Initially, a random effects analysis of variance (ANOVA) will be performed for each type of image (CT vs. MRI), for each phase (4 for CT and 5 for MRI) and for each method of measuring "size" (1-, 2-, and 3-dimensional) - for a total of 27 ANOVAs. Lesion, radiologist, and replication (for the 20 target lesions measured twice) will all be random effects; the inter-reader and the intra-reader variability will be estimated from these models and 95% confidence intervals will be constructed.
1 secondary outcome
Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
Time frame: Up to 24 hours
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 19 Oct 2015.
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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.
Gilbert Whang principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gadoxetate Disodium and Magnetic Resonance Imaging in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by University of Southern California 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 13 inclusion and 9 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 19 Oct 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability (time frame: Up to 24 hours). 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 19 Oct 2015.