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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00492 | Registry Identifier | NCI CTRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRE + 2PD MRI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Elastogram | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Image Quality of Magnetic Resonance Elastography (MRE) | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis | Assessed using Pearson correlation | Baseline to end of trial, up to 2 years |
| Hepatic Steatosis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haesun Choi, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Image Quality of Magnetic Resonance Elastography (MRE) | MRE Data processing not conducted, therefore data could not be generated. | Posted | 2 Years |
|
Baseline to end of trial, up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haesun Choi, MD/Professor, Abdominal Imaging Department | UT MD Anderson Cancer Center | (713) 745-4693 | hchoi@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | Jan 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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|
|
| 2-Point Dixon Magnetic Resonance Imaging | Diagnostic Test | Imaging performed after the MRE procedure and lasting 20-60 seconds. This procedure is useful in identifying fat tissue. |
|
|
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).
| Baseline to the end of the trial, up to 2 years |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Association Between Degrees of Stiffness Measured by MRE in kPa and Histopathological Grades of Fibrosis and Steatohepatitis | Assessed using Pearson correlation | 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. | Posted | Baseline to end of trial, up to 2 years |
|
|
| 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). | Participants analyzed are those with liver tumors requiring hepatic resection. | Posted | Mean | Standard Deviation | percentage of fat fraction | Baseline to the end of the trial, up to 2 years |
|
|
|
| 0 |
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
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| D005355 |
| Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |