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Contrast-enhanced Ultrasound Evaluation of Chemoembolization

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ClinicalTrials.gov Identifier: NCT02764801
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : September 1, 2021
Sponsor:
Collaborators:
University of California, San Diego
Vanderbilt University Medical Center
National Institutes of Health (NIH)
Lantheus Medical Imaging
GE Healthcare
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and 4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE) response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic resonance (MRI) or computed tomography (CT) imaging

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Chemoembolization, Therapeutic Drug: Ultrasound contrast agent (Contrast-enhanced ultrasound) Device: Logiq E9 Scanner (Contrast-enhanced ultrasound) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 2D and 4D Contrast-enhanced Ultrasound Evaluation of Hepatocellular Carcinoma Chemoembolization
Study Start Date : April 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Contrast ultrasound arm
Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response.
Drug: Ultrasound contrast agent (Contrast-enhanced ultrasound)
Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.
Other Names:
  • Definity (Lantheus Medical Imaging)
  • Microbubble contrast agent

Device: Logiq E9 Scanner (Contrast-enhanced ultrasound)
Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Other Name: Ultrasound Scanner




Primary Outcome Measures :
  1. Percentage of patients correctly identified as requiring tumor re-treatment two weeks after initial chemoembolization [ Time Frame: Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure ]
    The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1-2 weeks post chemoembolization.

  2. Percentage of patients correctly identified as requiring tumor re-treatment one month after initial chemoembolization [ Time Frame: Percentage of patients correctly identified as requiring re-treatment will be identified 1 month after the subject's chemoembolization procedure ]
    The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1 month post chemoembolization.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients >= 21 years of age
  • Patient capable of making informed decisions regarding his/her treatment
  • Scheduled for TACE treatment of a HCC mass (lesions reported as Liver Imaging Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a or 5b)
  • Negative pregnancy test in a female of child-bearing age.
  • Have an HCC mass viewable on grayscale B-mode ultrasound.

Exclusion Criteria:

  • Females who are pregnant or nursing.
  • Patients not eligible or scheduled for TACE of a HCC mass.
  • Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h after their final CEUS exam.
  • Patients who have received prior radioembolization (Y90) of the lesion of interest.
  • Patients with known or suspected cardiac shunts.
  • Patients with pulmonary hypertension or unstable cardiopulmonary conditions.
  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
  • Patients with unstable occlusive disease (e.g., crescendo angina)
  • Patients with clinically unstable cardiac arrhythmias
  • Patients with uncontrolled congestive heart failure (NYHA Class IV)

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): NCT02764801


Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Yuko Kono, MD, PhD       ykono@ucsd.edu   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Michael Soulen, MD       Michael.Soulen@uphs.upenn.edu   
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: John R Eisenbrey, PhD    215-503-5188    john.eisenbrey@jefferson.edu   
United States, Tennessee
Vanderbilt University Withdrawn
Nashville, Tennessee, United States, 37235
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
University of California, San Diego
Vanderbilt University Medical Center
National Institutes of Health (NIH)
Lantheus Medical Imaging
GE Healthcare
Additional Information:
Publications:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02764801    
Other Study ID Numbers: 15F.579
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases