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

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 |
Arm | Intervention/treatment |
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Experimental: Contrast ultrasound arm
Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response.
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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:
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 |
- 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.
- 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 |
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)

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
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 |
Publications:
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 |
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 |