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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045497
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Perflutren Lipid Microspheres Device: Dynamic Contrast-Enhanced Ultrasound Imaging Device: Contrast-enhanced Magnetic Resonance Imaging Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
Actual Study Start Date : December 12, 2012
Actual Primary Completion Date : December 5, 2013
Actual Study Completion Date : December 5, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Perflutren

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 Name: 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 Name: Contrast-enhanced MRI




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045497


Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Flemming Forsberg, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03045497    
Other Study ID Numbers: 12D.614
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases