Phase 3
Completed N=131
Contrast-enhanced Ultrasound Evaluation of Chemoembolization
Hepatocellular Carcinoma · Chemoembolization, Therapeutic
Source: ClinicalTrials.gov NCT02764801 ↗
Enrolled (actual)
131
Serious AEs
3.9%
Results posted
Sep 2023
Primary outcomePrimary: Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization — 94 percentage
◆ Published Evidence
Established
24citations · ~8 / year
Contrast-enhanced US Evaluation of Hepatocellular Carcinoma Response to Chemoembolization: A Prospective Multicenter Trial.
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
Linked Publications
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Contrast-enhanced US Evaluation of Hepatocellular Carcinoma Response to Chemoembolization: A Prospective Multicenter Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization |
94 | — |
| PRIMARY Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment One Month After Initial Chemoembolization |
91 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02764801) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.