Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 6:29 PM
Study NCT ID:
NCT02578602
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2015-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: