Clinical trial NCT04569799: Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE
Official title: Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Detailed description: This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare.

Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE.

Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit.

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.

Primary outcomes:
measure: Residual Disease on CEUS Imaging.
timeFrame: 2-4 months post TACE
measure: Residual Disease on CT/MRI Imaging
timeFrame: 2-4 months post-TACE
measure: No Viable Disease on CEUS Imaging.
timeFrame: 2-4 months post-TACE
measure: No Viable Disease on CT/MRI Imaging.
timeFrame: 2-4 months post-TACE
Secondary outcomes:
measure: Lesions Missed or Miscategorized on CEUS Imaging.
timeFrame: 4-8 months post-TACE
measure: Lesions Missed or Miscategorized on CT/MRI Imaging.
timeFrame: 4-8 months post-TACE
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Kathryn McGillen
role: PRINCIPAL_INVESTIGATOR
References: