Recruiting
Phase 2

Contrast Enhanced Ultrasound

Sponsor:

john eisenbrey

Code:

NCT06261814

Conditions

Liver Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sulfur Hexafluoride Lipid Microspheres

Contrast-Enhanced Ultrasound

Transarterial Chemoembolization

Medical Chart Review

Study Details

Brief summary:

This phase II trial evaluates the diagnostic performance of contrast-enhanced ultrasound (CEUS) for assessing treatment response in patients undergoing transarterial chemoembolization (TACE) for liver tumors. TACE is a hepatic artery embolization technique involving the injection of a blocking agent and a chemotherapy agent to treat liver cancers. Currently, contrast enhanced magnetic resonance imaging or computed tomography are used to assess disease response 1-2 months after TACE treatment, but ultrasound may be a less expensive, earlier alternative. CEUS is an imaging procedure that uses high-frequency sound waves to generate images of the body after administering Lumason, an imaging agent used to enhance visualization of blood flow on ultrasounds. CEUS is able to be performed during the TACE procedure, making it possible to evaluate treatment response earlier than standard techniques. CEUS may be an effective method to evaluate treatment response more accurately and much earlier than current standard evaluation methods.

Conditions

Liver Neoplasms

Study ID

NCT06261814

Start date

Aug 7, 2024

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Scheduled for TACE therapy of a liver tumor
  • Be at least 18 years of age
  • Be medically stable
  • If a female of child-bearing age, must have a negative pregnancy test
  • Have signed informed consent to participate in the study

Exclusion Criteria:

  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable
  • Patients with known sensitivities to the components of lumason

Study Design

Enrollment

266 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (CEUS)

Patients receive lumason IV and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.

Intervention(s)

Interventions

Sulfur Hexafluoride Lipid Microspheres

Given IV

Contrast-Enhanced Ultrasound

Undergo CEUS

Transarterial Chemoembolization

Undergo TACE

Medical Chart Review

Ancillary studies

Primary outcome measure

  • Recurrence [ Time Frame: Up to 6 months ]
  • Sensitivity [ Time Frame: Up to 6 months ]
  • Specificity [ Time Frame: Up to 6 months ]
  • Positive predictive value [ Time Frame: Up to 6 months ]
  • Negative predictive value [ Time Frame: Up to 6 months ]
  • False discovery rate [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

Sidney Kimmel Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

More Information

Sponsor

john eisenbrey

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by john eisenbrey on 2026-02-17.