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Chemotherapy

Contrast-Enhanced Ultrasound for Liver Cancer

Phase 2

Waitlist Available

Research Sponsored by john eisenbrey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for TACE therapy of a liver tumor

If a female of child-bearing age, must have a negative pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial assesses the use of a specific type of ultrasound, called contrast-enhanced ultrasound (CEUS), to see how well it can determine if the treatment is working for liver tumors in patients undergoing

Who is the study for?

This trial is for patients with liver tumors who are undergoing a treatment called transarterial chemoembolization (TACE). Participants should be eligible for TACE and able to undergo contrast-enhanced ultrasound (CEUS) imaging. The study aims to include those who can provide informed consent and have no conditions that would interfere with CEUS.

What is being tested?

The trial is testing the use of contrast-enhanced ultrasound (CEUS) during TACE procedures in liver tumor patients. It compares CEUS's ability to assess treatment response earlier against standard methods like MRI or CT scans, which are done later.

What are the potential side effects?

Potential side effects may include discomfort from the ultrasound procedure, allergic reactions to the contrast agent Lumason, and typical risks associated with TACE such as abdominal pain, fever, or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific liver tumor treatment.

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I am of child-bearing age and my pregnancy test is negative.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

False discovery rate

Negative predictive value

Positive predictive value

+2 more

Secondary study objectives

Ability of the model to predict binary treatment response

Diagnostic performance for each imaging mode

Residual tumor vacularity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (CEUS)Experimental Treatment4 Interventions

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transarterial Chemoembolization

2009

Completed Phase 1

~100

Sulfur Hexafluoride Lipid Microspheres

2018

Completed Early Phase 1

~10