search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Perflutren Lipid Microspheres
Dynamic Contrast-Enhanced Ultrasound Imaging
Contrast-enhanced Magnetic Resonance Imaging
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (contrast-enhanced ultrasound)

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change in quantitative blood flow parameters
    Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.
    Quantitative parameters of tumor vascularity
    Changes in perfusion
    Changes in contrast fill time

    Full Information

    First Posted
    January 31, 2017
    Last Updated
    February 3, 2017
    Sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03045497
    Brief Title
    Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads
    Official Title
    Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 12, 2012 (Actual)
    Primary Completion Date
    December 5, 2013 (Actual)
    Study Completion Date
    December 5, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sidney Kimmel Cancer Center at Thomas Jefferson University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (contrast-enhanced ultrasound)
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Perflutren Lipid Microspheres
    Other Intervention Name(s)
    Definity
    Intervention Description
    Given IV
    Intervention Type
    Device
    Intervention Name(s)
    Dynamic Contrast-Enhanced Ultrasound Imaging
    Intervention Description
    Undergo contrast-enhanced ultrasound imaging
    Intervention Type
    Device
    Intervention Name(s)
    Contrast-enhanced Magnetic Resonance Imaging
    Other Intervention Name(s)
    Contrast-enhanced MRI
    Intervention Description
    Undergo contrast-enhanced Magnetic Resonance Imaging
    Primary Outcome Measure Information:
    Title
    Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
    Description
    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.
    Time Frame
    Up to 1 month after transarterial chemoembolization
    Secondary Outcome Measure Information:
    Title
    Change in quantitative blood flow parameters
    Description
    Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.
    Time Frame
    Baseline to up to 1 month after transarterial chemoembolization
    Title
    Quantitative parameters of tumor vascularity
    Time Frame
    Baseline to up to 1 month after transarterial chemoembolization
    Title
    Changes in perfusion
    Time Frame
    Baseline to up to 1 month after transarterial chemoembolization
    Title
    Changes in contrast fill time
    Time Frame
    Baseline to up to 1 month after transarterial chemoembolization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Flemming Forsberg, PhD
    Organizational Affiliation
    Sidney Kimmel Cancer Center at Thomas Jefferson University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://hospitals.jefferson.edu/
    Description
    Thomas Jefferson University Hospital

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs