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

Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Perflutren Lipid Microspheres; Device: Dynamic Contrast-Enhanced Ultrasound Imaging; Device: Contrast-enhanced Magnetic Resonance Imaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (contrast-enhanced ultrasound); 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.

Drug: Perflutren Lipid Microspheres; Given IV; Other Names: Definity; Device: Dynamic Contrast-Enhanced Ultrasound Imaging; Undergo contrast-enhanced ultrasound imaging; Device: Contrast-enhanced Magnetic Resonance Imaging; Undergo contrast-enhanced Magnetic Resonance Imaging; Other Names: Contrast-enhanced MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads	Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated.	Up to 1 month after transarterial chemoembolization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quantitative blood flow parameters	Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.	Baseline to up to 1 month after transarterial chemoembolization
Quantitative parameters of tumor vascularity		Baseline to up to 1 month after transarterial chemoembolization
Changes in perfusion		Baseline to up to 1 month after transarterial chemoembolization
Changes in contrast fill time		Baseline to up to 1 month after transarterial chemoembolization

Collaborators and Investigators

• Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
• Investigators: Principal Investigator: Flemming Forsberg, PhD, Sidney Kimmel Cancer Center at Thomas Jefferson University

Publications and helpful links

Helpful Links

• Thomas Jefferson University Hospital
• Sidney Kimmel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2012
• Primary Completion (Actual): December 5, 2013
• Study Completion (Actual): December 5, 2013

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimated): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: May 1, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 12D.614; JT 2999 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No