Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status and phase: Completed; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Device: Contrast-enhanced Magnetic Resonance Imaging; Drug: Perflutren Lipid Microspheres; Device: Dynamic Contrast-Enhanced Ultrasound Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT03045497

12D.614

JT 2999 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer.

Full description

PRIMARY OBJECTIVES:

I. Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads.

SECONDARY OBJECTIVES:

I. Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma
• Be medically stable
• If a female of child-bearing potential, must have a negative pregnancy test
• Have signed Informed Consent to participate in the study

Exclusion criteria

• Females who are pregnant or nursing

• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

  • Patients on life support or in a critical care unit
  • Patients with unstable occlusive disease (eg, crescendo angina)
  • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
  • Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)

• Patients with recent cerebral hemorrhage

• Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection)

• Patients who have undergone surgery within 24 hours prior to the study sonographic examination

• Patients with known hypersensitivity to perflutren

• Patients who have received any contrast medium (x-ray, MRI, computed tomography [CT], or ultrasound [US]) in the 24 hours prior to the research US exam

• Patients with cardiac shunts

• Patients with congenital heart defects

• Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli

• Patients with respiratory distress syndrome

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Diagnostic (contrast-enhanced ultrasound)

Experimental group

Description:

Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.

Treatment:

Device: Dynamic Contrast-Enhanced Ultrasound Imaging

Drug: Perflutren Lipid Microspheres

Device: Contrast-enhanced Magnetic Resonance Imaging