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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045497
• Other study ID #: 12D.614
• Status: Completed
• Phase: Phase 1
• First received: January 31, 2017
• Last updated: February 3, 2017
• Start date: December 12, 2012
• Est. completion date: December 5, 2013

Study information

• Verified date: February 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 5, 2013
• Est. primary completion date: December 5, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Perflutren Lipid Microspheres
Given IV

Device:
• Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo contrast-enhanced ultrasound imaging
• Contrast-enhanced Magnetic Resonance Imaging
Undergo contrast-enhanced Magnetic Resonance Imaging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Quantitative parameters of tumor vascularity		Baseline to up to 1 month after transarterial chemoembolization
Secondary	Changes in perfusion		Baseline to up to 1 month after transarterial chemoembolization
Secondary	Changes in contrast fill time		Baseline to up to 1 month after transarterial chemoembolization

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital