Trials / Completed
CompletedNCT02578602
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- University of Southern California · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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: 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.
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
- BCLC Stage D Adult Hepatocellular Carcinoma
- Localized Non-Resectable Adult Liver Carcinoma
- Localized Resectable Adult Liver Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gadoxetate Disodium | Given IV |
| DEVICE | Magnetic Resonance Imaging | Undergo MRI with gadoxetate disodium |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2014-11-01
- Completion
- 2015-06-01
- First posted
- 2015-10-19
- Last updated
- 2015-10-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02578602. Inclusion in this directory is not an endorsement.