Clinical trial · Interventional
Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads
Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
- 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 pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced Magnetic Resonance Imaging | Device | — | UNRESOLVED |
| Dynamic Contrast-Enhanced Ultrasound Imaging | Device | — | UNRESOLVED |
| Perflutren Lipid Microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (contrast-enhanced ultrasound)
- description
- Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.
- interventionNames
- Drug: Perflutren Lipid Microspheres
- Device: Dynamic Contrast-Enhanced Ultrasound Imaging
- Device: Contrast-enhanced Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
- timeFrame
- Up to 1 month after transarterial chemoembolization
- description
- Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma * Be medically stable * If a female of child-bearing potential, must have a negative pregnancy test * Have signed Informed Consent to participate in the study Exclusion Criteria: * Females who are pregnant or nursing * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example: * Patients on life support or in a critical care unit * Patients with unstable occlusive disease (eg, crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia * Patients with uncontrolled congestive heart failure (New York Heart Association \[NYHA\] class IV) * Patients with recent cerebral hemorrhage * Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection) * Patients who have undergone surgery within 24 hours prior to the study sonographic examination * Patients with known hypersensitivity to perflutren * Patients who have received any contrast medium (x-ray, MRI, computed tomography \[CT\], or ultrasound \[US\]) in the 24 hours prior to the research US exam * Patients with cardiac shunts * Patients with congenital heart defects * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli * Patients with respiratory distress syndrome
References
Publications (0)
Data not yet available