Liver NeoplasmsPhase 2NCT06261814
Contrast Enhanced Ultrasound to Evaluate Response to Chemoembolization in Patients With Liver Tumors
A Phase 2 study testing Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Transarterial Chemoembolization in people with Liver Neoplasms, run by john eisenbrey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Transarterial Chemoembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2024to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 2D and 3D Contrast Enhanced Ultrasound of Chemoembolization
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the sensitivity and specificity of CEUS for the evaluation of TACE treatment response in a variety of solid liver tumors (years 1-4).
SECONDARY OBJECTIVES:
- To determine the ability of CEUS to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4).
II. To explore a variety of advanced imaging approaches to improve on the suboptimal specificity of CEUS for identifying residual viable tumor following TACE (years 1-5).
III. To investigate the ability of CEUS obtained prior to TACE to quantitatively assess tumor vascular morphology and predict response to therapy (years 2-5).
EXPLORATORY OBJECTIVE:
- Use acquired B-mode in-phase and quadrature (IQ) data for H-scan imaging.
OUTLINE:
Patients receive sulfur hexafluoride lipid microspheres (Lumason) intravenously (IV) and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
After completion of study treatment, patients are followed up at 6 months.
- Conditions
- Liver Neoplasms
- Being tested
- Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound, Transarterial Chemoembolization, Medical Chart Review
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulfur Hexafluoride Lipid MicrospheresDrug
Also called Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A Microspheres
Given IV
Contrast-Enhanced UltrasoundProcedure or surgery
Also called CEUS
Undergo CEUS
Transarterial ChemoembolizationProcedure or surgery
Also called TACE, Chemoembolization
Undergo TACE
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEUS) | Experimental | 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) Receives: Drug: Sulfur Hexafluoride Lipid Microspheres; Procedure: Contrast-Enhanced Ultrasound; Procedure: Transarterial Chemoembolization; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Negative 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.
Measured: Up to 6 months
False discovery rate
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.
Measured: Up to 6 months
Secondary outcomes (3)
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start7 Aug 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- No Data Available
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- john eisenbrey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, john eisenbrey, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261814
- Sponsor's protocol ID
- iRISID-2023-2142
- Other IDs
- JT 33825, R01CA194307
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2D and 3D Contrast Enhanced Ultrasound of Chemoembolization
- ClinicalTrials.gov ID
- NCT06261814
- Acronym / sponsor ID
- iRISID-2023-2142
- Conditions
- Liver Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- john eisenbreyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the sensitivity and specificity of CEUS for the evaluation of TACE treatment response in a variety of solid liver tumors (years 1-4).
SECONDARY OBJECTIVES:
- To determine the ability of CEUS to identify residual tumor vascularity intraoperatively, thereby enabling immediate retreatment when necessary (years 1-4).
II. To explore a variety of advanced imaging approaches to improve on the suboptimal specificity of CEUS for identifying residual viable tumor following TACE (years 1-5).
III. To investigate the ability of CEUS obtained prior to TACE to quantitatively assess tumor vascular morphology and predict response to therapy (years 2-5).
EXPLORATORY OBJECTIVE:
- Use acquired B-mode in-phase and quadrature (IQ) data for H-scan imaging.
OUTLINE:
Patients receive sulfur hexafluoride lipid microspheres (Lumason) intravenously (IV) and undergo CEUS 2 weeks prior to TACE, during TACE, 1-2 weeks after TACE, and then 1-2 months after TACE.
After completion of study treatment, patients are followed up at 6 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- No Data Available
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEUS) | Experimental | Drug: Sulfur Hexafluoride Lipid Microspheres, Procedure: Contrast-Enhanced Ultrasound, Procedure: Transarterial Chemoembolization, Other: Medical Chart ReviewPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sulfur Hexafluoride Lipid MicrospheresAlso: Lumason, SF6 Lipid Microspheres, Sulfur Hexafluoride Lipid-type A MicrospheresGiven IV | Drug | Diagnostic (CEUS) |
| Contrast-Enhanced UltrasoundAlso: CEUSUndergo CEUS | Procedure or surgery | Diagnostic (CEUS) |
| Transarterial ChemoembolizationAlso: TACE, ChemoembolizationUndergo TACE | Procedure or surgery | Diagnostic (CEUS) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Diagnostic (CEUS) |
Primary outcome
Recurrence
Time frame: Up to 6 months
Sensitivity
Time frame: Up to 6 months
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.
Specificity
Time frame: Up to 6 months
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.
Positive predictive value
Time frame: Up to 6 months
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.
Negative predictive value
Time frame: Up to 6 months
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.
False discovery rate
Time frame: Up to 6 months
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.
3 secondary outcomes
Residual tumor vacularity
Time frame: Up to 6 months
Diagnostic performance for each imaging mode
Time frame: Up to 6 months
Ability of the model to predict binary treatment response
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sulfur Hexafluoride Lipid Microspheres, Contrast-Enhanced Ultrasound and Transarterial Chemoembolization in people with Liver Neoplasms, run by john eisenbrey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Eisenbrey, PhD (215-503-5188, john.eisenbrey@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: Up to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.