Clinical trial · Interventional
Contrast-enhanced Ultrasound Evaluation of Chemoembolization
2D and 4D Contrast-enhanced Ultrasound Evaluation of Hepatocellular Carcinoma Chemoembolization
NCT02764801CI-TRIAL-00089358completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoembolization, Therapeutic | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Logiq E9 Scanner (Contrast-enhanced ultrasound) | Device | — | UNRESOLVED |
| Ultrasound contrast agent (Contrast-enhanced ultrasound) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast ultrasound arm
- description
- Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response.
- interventionNames
- Drug: Ultrasound contrast agent (Contrast-enhanced ultrasound)
- Device: Logiq E9 Scanner (Contrast-enhanced ultrasound)
Primary outcomes (2)
- measure
- 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
- description
- 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.
- measure
- Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment One Month After Initial Chemoembolization
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDShaw CM, Eisenbrey JR, Lyshchik A, O'Kane PL, Merton DA, Machado P, Pino L, Brown DB, Forsberg F. Contrast-enhanced ultrasound evaluation of residual blood flow to hepatocellular carcinoma after treatment with transarterial chemoembolization using drug-eluting beads: a prospective study. J Ultrasound Med. 2015 May;34(5):859-67. doi: 10.7863/ultra.34.5.859. PMID 25911704
- BACKGROUNDKono Y, Lucidarme O, Choi SH, Rose SC, Hassanein TI, Alpert E, Mattrey RF. Contrast-enhanced ultrasound as a predictor of treatment efficacy within 2 weeks after transarterial chemoembolization of hepatocellular carcinoma. J Vasc Interv Radiol. 2007 Jan;18(1 Pt 1):57-65. doi: 10.1016/j.jvir.2006.10.016. PMID 17296705
- DERIVEDSavsani E, Shaw CM, Forsberg F, Wessner CE, Lyshchik A, O'Kane P, Liu JB, Balasubramanya R, Roth CG, Naringrekar H, Keith SW, Tan A, Anton K, Bradigan K, Civan J, Schultz S, Shamimi-Noori S, Hunt S, Soulen MC, Mattrey RF, Kono Y, Eisenbrey JR. Contrast-enhanced US Evaluation of Hepatocellular Carcinoma Response to Chemoembolization: A Prospective Multicenter Trial. Radiology. 2023 Oct;309(1):e230727. doi: 10.1148/radiol.230727. PMID 37847138