Accuracy of Contrast-Enhanced Ultrasound for Hepatocellular Carcinoma Post TACE

NCT04569799 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY14930
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• Lesions Missed or Miscategorized on CEUS Imaging.

  4-8 months post-TACE

• Lesions Missed or Miscategorized on CT/MRI Imaging.

  4-8 months post-TACE

Study Arms (1)

group-1

OTHER

Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS),

Drug: Lumason

Interventions

Lumason DRUG

2.4 mL per lesion

Also known as: SonoVue, sulfur hexafluoride

group-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

contrast agent BR1; Sulfur Hexafluoride

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds

Limitations and Caveats

Small sample number, pilot study

Results Point of Contact

• Title: Kathryn McGillen, M.D.
• Organization: Penn State Health College of Medicine

kmcgillen@pennstatehealth.psu.edu

717-531-0003

Study Officials

• Kathryn McGillen

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Radiology

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 30, 2020
• Study Start: October 14, 2020
• Primary Completion: October 11, 2022
• Study Completion: October 11, 2022
• Last Updated: November 2, 2023
• Results First Posted: November 2, 2023

Record last verified: 2023-10

Locations

US (1)