Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

Hepatocellular Carcinoma Clinical Trial

— TACE  

Official title:

Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma (HCC) Post Transcatheter Arterial Chemoembolization (TACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04569799
• Other study ID #: STUDY14930
• Status: Completed
• Phase: Phase 4
• Start date: October 14, 2020
• Est. completion date: October 11, 2022

Study information

• Verified date: October 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Lumason
2.4 mL per lesion

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual Disease on CEUS Imaging.	Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS.	2-4 months post TACE
Primary	Residual Disease on CT/MRI Imaging	Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI.	2-4 months post-TACE
Primary	No Viable Disease on CEUS Imaging.	Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS.	2-4 months post-TACE
Primary	No Viable Disease on CT/MRI Imaging.	Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI.	2-4 months post-TACE
Secondary	Lesions Missed or Miscategorized on CEUS Imaging.	Number of lesions missed or miscategorized on CEUS imaging.	4-8 months post-TACE
Secondary	Lesions Missed or Miscategorized on CT/MRI Imaging.	Number of lesions missed or miscategorized on CT/MRI imaging.	4-8 months post-TACE