MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer

NCT02578602 | Completed Phase 1

• 5 other identifiers: 3L-10-1NCI-2014-01850USC 3L-10-1HS-10-00188P30CA014089
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate

  Up to 24 hours

Study Arms (1)

Diagnostic (gadoxetate disodium MRI)

EXPERIMENTAL

Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.

Drug: Gadoxetate Disodium; Device: Magnetic Resonance Imaging

Interventions

Gadoxetate Disodium DRUG

Given IV

Also known as: Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid Disodium, Gd-(S)-EOB-DTPA, Gd-EOB-DTPA, Primovist, ZK 139834

Diagnostic (gadoxetate disodium MRI)

Magnetic Resonance Imaging DEVICE

Undergo MRI with gadoxetate disodium

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Diagnostic (gadoxetate disodium MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Imaging features of a mass
• Wash-out on later phases of contrast administration
• At least 1 cm or more growth
• For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
• Imaging features of a mass
• Wash-out on later phases of contrast administration
• At least 1 cm or more growth
• 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

You may not qualify if:

• Unable to provide written and verbal informed consent
• Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
• Pregnancy
• Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
• Severe liver disease as defined by Childs class C cirrhosis
• History of a previous reaction to contrast media
• History of bronchial asthma
• History of allergic disorders
• Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gadolinium ethoxybenzyl DTPA; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Gilbert Whang

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

US (1)