CompletedPhase 3

Contrast-enhanced Ultrasound Evaluation of Chemoembolization

United States131 participantsStarted 2016-04

Plain-language 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

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization

Timeframe: Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure

Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment One Month After Initial Chemoembolization

Timeframe: Percentage of patients correctly identified as requiring re-treatment will be identified 1 month after the subject's chemoembolization procedure

Trial details

NCT IDNCT02764801

SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

Results submitted2023-06-28

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials