Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
john eisenbrey
Study ID
NCT06261814
Phase
PHASE2
Status
Recruiting
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Conditions

  • Liver Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sulfur Hexafluoride Lipid Microspheres — DRUG
    Given IV
  • Contrast-Enhanced Ultrasound — PROCEDURE
    Undergo CEUS
  • Transarterial Chemoembolization — PROCEDURE
    Undergo TACE
  • Medical Chart Review — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 7, 2024
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
266 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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)

Primary Outcome Measure

Recurrence [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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By research site
Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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