MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
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|ClinicalTrials.gov Identifier: NCT02578602|
Recruitment Status : Completed
First Posted : October 19, 2015
Last Update Posted : October 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|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 BCLC Stage D Adult Hepatocellular Carcinoma Localized Non-Resectable Adult Liver Carcinoma Localized Resectable Adult Liver Carcinoma||Drug: Gadoxetate Disodium Device: Magnetic Resonance Imaging||Phase 1|
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.
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||June 2015|
Experimental: Diagnostic (gadoxetate disodium MRI)
Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
Drug: Gadoxetate Disodium
Device: Magnetic Resonance Imaging
Undergo MRI with gadoxetate disodium
- 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.
- 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 ]ADC values will be recorded for uninvolved liver parenchyma and for tumors before and after administration of gadoxetate disodium.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578602
|United States, California|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Gilbert Whang||University of Southern California|