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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
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 email@example.com|
|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 firstname.lastname@example.org|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37235|