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

NCT03045497 | Completed Phase 1 FDA Drug

• 2 other identifiers: 12D.614JT 2999
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in quantitative blood flow parameters

  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

Study Arms (1)

Diagnostic (contrast-enhanced ultrasound)

EXPERIMENTAL

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; Device: Dynamic Contrast-Enhanced Ultrasound Imaging; Device: Contrast-enhanced Magnetic Resonance Imaging

Interventions

Perflutren Lipid Microspheres DRUG

Given IV

Also known as: Definity

Diagnostic (contrast-enhanced ultrasound)

Dynamic Contrast-Enhanced Ultrasound Imaging DEVICE

Undergo contrast-enhanced ultrasound imaging

Diagnostic (contrast-enhanced ultrasound)

Contrast-enhanced Magnetic Resonance Imaging DEVICE

Undergo contrast-enhanced Magnetic Resonance Imaging

Also known as: Contrast-enhanced MRI

Diagnostic (contrast-enhanced ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Related Links

• Sidney Kimmel Cancer Center
• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

perflutren; Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Flemming Forsberg, PhD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2017
• First Posted: February 7, 2017
• Study Start: December 12, 2012
• Primary Completion: December 5, 2013
• Study Completion: December 5, 2013
• Last Updated: May 2, 2025

Record last verified: 2025-05