Clinical trial NCT02578602: MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
Official title: MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-10-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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:

    * 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Changes in apparent diffusion coefficient (ADC) values within lesions and within normal liver before and after administration of Gadoxetate
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Gilbert Whang
role: PRINCIPAL_INVESTIGATOR
References: