Liver Cancer
Conditions
Keywords
Liver Cancer, Magnetic Resonance Elastography, 2-Point Dixon Magnetic Resonance Imaging, Liver Disease, Fatty Liver, Liver Fibrosis, Liver Cirrhosis, MRE, 2PD MRI, phase correction algorithm
Brief summary
The goal of this clinical research study is to test the accuracy of magnetic resonance elastogram (MRE) and 2-point dixon magnetic resonance imaging (2PD MRI) using new computer software (called phase correction algorithm) in patients who might have liver disease.
Detailed description
Finding liver damage as early as possible is important. Traditionally, biopsies have been used for this purpose. Biopsies are accurate but can only check a small part of the liver. Tissue fat and liver stiffness are common in patients with liver disease.This study is testing new MRI techniques (called an MRE) that may be able to test for these symptoms on the entire liver, in a short time. A typical MRI uses a large magnet instead of x-rays to take pictures of the inside of your body. The MRE will be done on a standard MRI scanner. Study Visit: The MRE procedure is useful for identifying tissue stiffness. For the MRE procedure, you will lie on your back on the examination table, and a pneumatic driver (a light-weight, clear plastic drum, about 10 inches wide and 1 inch thick) will be placed over the upper abdomen. You will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. The MRE will take about 40 seconds. The driver will only be turned on during this time. Once the MRE is completed, you will then have a 2PD MRI scan while you are still lying on the table. This procedure is useful in identifying fat tissue. This will take about 20-60 seconds. The total exam time will be no more than 20 minutes, including the preparation time. Once the MRI is completed, you will have a liver biopsy as part of your standard care. You will sign a separate consent form for this procedure. After the biopsy is performed, your participation in the study will be complete. This is an investigational study. The scanners and software for 2PD MRI used for this study are FDA-approved and being used in clinical practice. The MRE technique used for this study has not been FDA-approved. At this time, the MRE technique is being used in research only. The use of study data for the purpose of this study is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Elastogram
Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.
DIAGNOSTIC_TEST2-Point Dixon Magnetic Resonance Imaging
Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Group 1. Non-oncologic patients from VAMC in Houston: 2. Biopsy proven or clinically suspected advanced parenchymal liver disease 3. Core biopsies obtained within 1-month of MRI/MRE 4. No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy 5. Signed consent 6. Group 2. Oncologic patients at MDACC: 7. Clinically or radiographically suspected liver damage, hepatic steatosis, hepatitis, hepatic fibrosis or cirrhosis 8. Surgical or core biopsy scheduled within 4 weeks of MRI/MRE 9. Signed consent
Exclusion criteria
1. Claustrophobia 2. Contraindications for MRI 3. Unable to hold a breath 4. Ascites or other clinical or radiographical signs of portal hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Image Quality of Magnetic Resonance Elastography (MRE) | 2 Years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis | Baseline to end of trial, up to 2 years | Assessed using Pearson correlation |
| Hepatic Steatosis | Baseline to the end of the trial, up to 2 years | Development of a non-invasive means to quantify hepatic steatosis using 2-Point Dixon technique for patients with \>30% steatosis compared to participants with \<30% steatosis. The degree of steatosis was quantified by percent fat fraction (%FF). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRE + 2PD MRI MRE - Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue. 2PD MRI - Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue.
Magnetic Resonance Elastogram: Pneumatic driver will be placed over the upper abdomen. Patient will feel a vibration (like a cell phone or beeper vibrating). This vibration will create very small waves in the body. The scanner will then receive the vibrations from the liver and use them to create images of the liver tissue.
2-Point Dixon Magnetic Resonance Imaging: Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | MRE + 2PD MRI | — |
|---|---|---|
| Age, Continuous | 47 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 44 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 27 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44 |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Overall Image Quality of Magnetic Resonance Elastography (MRE)
Time frame: 2 Years
Population: MRE Data processing not conducted, therefore data could not be generated.
Secondary
Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis
Assessed using Pearson correlation
Time frame: Baseline to end of trial, up to 2 years
Population: Association between degrees of stiffness measured by MRE in kPa and histopathological grades of fibrosis and steatohepatitis processing not conducted, therefore data could not generated.
Secondary
Hepatic Steatosis
Development of a non-invasive means to quantify hepatic steatosis using 2-Point Dixon technique for patients with \>30% steatosis compared to participants with \<30% steatosis. The degree of steatosis was quantified by percent fat fraction (%FF).
Time frame: Baseline to the end of the trial, up to 2 years
Population: Participants analyzed are those with liver tumors requiring hepatic resection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MRE + 2PD MRI | Hepatic Steatosis | >30% Steatosis | 22 percentage of fat fraction | Standard Deviation 5.2 |
| MRE + 2PD MRI | Hepatic Steatosis | <30% Steatosis | 5.0 percentage of fat fraction | Standard Deviation 2.1 |