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Completed

NCT Number: NCT03045497

Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perflutren Lipid Microspheres

Drug

Given IV

Other names: Definity

Dynamic Contrast-Enhanced Ultrasound Imaging

Device

Undergo contrast-enhanced ultrasound imaging

Contrast-enhanced Magnetic Resonance Imaging

Device

Undergo contrast-enhanced Magnetic Resonance Imaging

Other names: Contrast-enhanced MRI

Primary outcomes

  1. Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads

    Time frame: Up to 1 month after transarterial chemoembolization

    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.

Secondary outcomes

  1. Change in quantitative blood flow parameters

    Time frame: Baseline to up to 1 month after transarterial chemoembolization

    Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.

  2. Quantitative parameters of tumor vascularity

    Time frame: Baseline to up to 1 month after transarterial chemoembolization

  3. Changes in perfusion

    Time frame: Baseline to up to 1 month after transarterial chemoembolization

  4. Changes in contrast fill time

    Time frame: Baseline to up to 1 month after transarterial chemoembolization

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 7, 2017
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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