Actively Recruiting
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
Led by john eisenbrey · Updated on 2026-02-17
266
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
john eisenbrey
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of contrast-enhanced ultrasound (CEUS) to assess how well patients with liver tumors respond to transarterial chemoembolization (TACE). TACE is a treatment that blocks blood flow to liver cancers while delivering chemotherapy. This study is a phase II trial aiming to see if CEUS can detect treatment effects earlier and more accurately than current standard imaging methods like MRI or CT scans. Participants receive an intravenous injection of Lumason, a contrast agent that helps visualize blood flow during ultrasound imaging. CEUS is performed multiple times: two weeks before TACE, during the TACE procedure, one to two weeks after TACE, and again one to two months afterward. After completing these imaging sessions, patients are followed up for six months to monitor their progress. During the study, patients undergo CEUS scans at set intervals combined with the TACE treatment to evaluate tumor response. Researchers will measure outcomes such as recurrence, sensitivity, specificity, and predictive values related to CEUS performance for up to six months. The study also explores advanced imaging techniques to improve the accuracy of CEUS and investigates whether pre-treatment CEUS can predict therapy response. Patient safety and treatment effects are closely monitored throughout the study period.
CONDITIONS
Brief Title
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for transarterial chemoembolization (TACE) therapy of a liver tumor
- At least 18 years of age
- Medically stable
- If female of child-bearing age, must have a negative pregnancy test
- Signed informed consent to participate in the study
You will not qualify if you...
- Medically unstable, seriously or terminally ill, or having an unpredictable clinical course
- Known allergies to components of Lumason
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility and baseline assessments
Duration - 2 weeks prior to TACE
Participants receive intravenous sulfur hexafluoride lipid microspheres and undergo contrast-enhanced ultrasound (CEUS) imaging to evaluate tumor characteristics before transarterial chemoembolization (TACE).
1 visit (in-person) for CEUS imaging and IV contrast administration
Duration - Day of TACE procedure
Participants undergo TACE treatment with concurrent CEUS imaging using intravenous sulfur hexafluoride lipid microspheres to assess treatment response during the procedure.
1 visit (in-person) for TACE and CEUS imaging
Duration - 1 to 2 weeks after TACE
Participants undergo CEUS imaging with intravenous sulfur hexafluoride lipid microspheres 1 to 2 weeks after TACE to evaluate early treatment response.
1 visit (in-person) for CEUS imaging and IV contrast administration
Duration - 1 to 2 months after TACE
Participants undergo CEUS imaging with intravenous sulfur hexafluoride lipid microspheres 1 to 2 months after TACE to further assess treatment response.
1 visit (in-person) for CEUS imaging and IV contrast administration
Duration - Up to 6 months after treatment completion
Participants are followed up to monitor tumor status and evaluate long-term outcomes after completion of TACE treatment and CEUS assessments.
Follow-up visits as scheduled for monitoring
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
J
John Eisenbrey, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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