Clinical trial · Interventional
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
2D and 3D Contrast Enhanced Ultrasound of Chemoembolization
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Neoplasms | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-Enhanced Ultrasound | Procedure | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Sulfur Hexafluoride Lipid Microspheres | Drug | — | UNRESOLVED |
| Transarterial Chemoembolization | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CEUS)
- description
- Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE. Intervention(s)
- interventionNames
- Drug: Sulfur Hexafluoride Lipid Microspheres
- Procedure: Contrast-Enhanced Ultrasound
- Procedure: Transarterial Chemoembolization
- Other: Medical Chart Review
Primary outcomes (6)
- measure
- Recurrence
- timeFrame
- Up to 6 months
- measure
- Sensitivity
- timeFrame
- Up to 6 months
- description
- Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between hepatocellular carcinoma (HCC) and non-HCC and between all tumor subtypes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled for TACE therapy of a liver tumor * Be at least 18 years of age * Be medically stable * If a female of child-bearing age, must have a negative pregnancy test * Have signed informed consent to participate in the study Exclusion Criteria: * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable * Patients with known sensitivities to the components of lumason
References
Publications (0)
Data not yet available