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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01850 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| USC 3L-10-1 | |||
| HS-10-00188 | |||
| 3L-10-1 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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).
PRIMARY OBJECTIVES:
I. 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:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (gadoxetate disodium MRI) | Experimental | Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadoxetate Disodium | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 hours |
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Inclusion Criteria:
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:
For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilbert Whang | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| Magnetic Resonance Imaging | Device | Undergo MRI with gadoxetate disodium |
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|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C073590 | gadolinium ethoxybenzyl DTPA |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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