Phase 4
N=26
Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE
Hepatocellular Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT04569799 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Residual Disease on CEUS Imaging. — 19 lesions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lumason (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Disease on CEUS Imaging. |
19 | — |
| PRIMARY Residual Disease on CT/MRI Imaging |
17 | — |
| PRIMARY No Viable Disease on CEUS Imaging. |
12 | — |
| PRIMARY No Viable Disease on CT/MRI Imaging. |
16 | — |
| SECONDARY Lesions Missed or Miscategorized on CEUS Imaging. |
2 | — |
| SECONDARY Lesions Missed or Miscategorized on CT/MRI Imaging. |
6 | — |
Summary
The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment
Eligibility Criteria
Inclusion Criteria
- Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE.
- Sex: male or female
- BMI ≤ 40
Exclusion Criteria
- Children (<18), pregnant patients
- Patients who do not speak English
- Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason.
- Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
- Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity.
- Pregnant or nursing woman
- Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
Data sourced from ClinicalTrials.gov (NCT04569799). 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.