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

University of Southern California

Status and phase

Completed

Phase 1

Conditions

BCLC Stage 0 Adult Hepatocellular Carcinoma

Advanced Adult Hepatocellular Carcinoma

Adult Hepatocellular Carcinoma

BCLC Stage B Adult Hepatocellular Carcinoma

BCLC Stage C Adult Hepatocellular Carcinoma

Localized Non-Resectable Adult Liver Carcinoma

BCLC Stage D Adult Hepatocellular Carcinoma

BCLC Stage A Adult Hepatocellular Carcinoma

Localized Resectable Adult Liver Carcinoma

Treatments

Device: Magnetic Resonance Imaging

Drug: Gadoxetate Disodium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02578602

USC 3L-10-1

3L-10-1 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

HS-10-00188

NCI-2014-01850 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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