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Chemotherapy

Diagnostic (CEUS) for Liver Tumors

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

False discovery rate

Negative predictive value

Positive predictive value

+2 more

Secondary outcome measures

Ability of the model to predict binary treatment response

Diagnostic performance for each imaging mode

Residual tumor vacularity

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

~90

Sulfur Hexafluoride Lipid Microspheres

2018

Completed Early Phase 1

~10

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

john eisenbreyLead Sponsor

1 Previous Clinical Trials

210 Total Patients Enrolled

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,448 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this clinical trial?

"As per clinicaltrials.gov, recruitment for this study is currently closed. The trial was initially listed on 2/5/2024 and last updated on 2/7/2024. While this specific trial is not recruiting participants presently, there are a substantial number of 237 ongoing trials actively seeking eligible candidates."

Answered by AI

Has the FDA officially authorized Contrast-Enhanced Ultrasound for diagnostic purposes?

"In this Phase 2 trial, Diagnostic (CEUS) was rated as a 2 for safety by our team at Power, indicating that while there is existing safety data, efficacy evidence is still pending."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

john eisenbrey 2024. "Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261814.

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