Health TrialsbyHealthPanel

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

ConditionLiver Neoplasms
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsorjohn eisenbrey

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Sulfur Hexafluoride Lipid Microspheres

    Drug

    Given IV

  • Contrast-Enhanced Ultrasound

    Procedure/Surgery

    Undergo CEUS

  • Transarterial Chemoembolization

    Procedure/Surgery

    Undergo TACE

  • Medical Chart Review

    Other intervention

    Ancillary studies

Treatment groups

266 Participants
are divided into 1 treatment group
Group A: Diagnostic (CEUS)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Recurrence

Time frame
Up to 6 months
2

Sensitivity

Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between hepatocellular carcinoma (HCC) and non-HCC and between all tumor subtypes.

Time frame
Up to 6 months
3

Specificity

Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

Time frame
Up to 6 months
4

Positive predictive value

Will be computed using a reference standard. Variables will be summarized with descriptive statistics, such as means with standard deviations or frequency counts with percentage, across the cohort and within group of interest. Diagnostic accuracy will be compared between HCC and non-HCC and between all tumor subtypes.

Time frame
Up to 6 months

Secondary outcomes

1

Residual tumor vacularity

Will use diagnostic summary statistics and generalized estimating equations (GEE) logistic regression modeling. The bedside (interventional radiologist) versus offline (radiologist) reads will be compared using agreement, kappa statistics, and mixed modeling.

Time frame
Up to 6 months
2

Diagnostic performance for each imaging mode

The diagnostic performance for each reader will be quantified from the volumetric contrast enhanced ultrasound exams and post-processed images. Diagnostic performance for each imaging mode will be compared across all readers using the GEE logistic regression approach. Quantitative H-scan data will be compared between complete and incomplete responders using multiple linear regression or GEE regression modeling, depending on how well assumptions hold for the former.

Time frame
Up to 6 months
3

Ability of the model to predict binary treatment response

Model performance will be calculated using a leave-one-out cross-validation method to assess the ability of the model to predict binary treatment response. Accuracy, sensitivity and specificity will then be quantified and directly compared between 2 dimensional (D) and 3D datasets.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

john eisenbrey

Lead sponsor

Thomas Jefferson University

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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