Phase 3
N=131
Contrast-enhanced Ultrasound Evaluation of Chemoembolization
Hepatocellular Carcinoma · Chemoembolization, Therapeutic
Bottom Line
View on ClinicalTrials.gov: NCT02764801 ↗Enrolled (actual)
131
Serious AEs
3.9%
Results posted
Sep 2023
Primary outcome: Primary: Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization — 94 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ultrasound contrast agent (Contrast-enhanced ultrasound) (Drug); Logiq E9 Scanner (Contrast-enhanced ultrasound) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Dec 2021
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 | — |
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
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). 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.