Hepatocellular CarcinomaPhase 1NCT03045497

Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads

A Phase 1 study testing Perflutren Lipid Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging and Contrast-enhanced Magnetic Resonance Imaging in people with Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hepatocellular Carcinoma
What is being tested?: Perflutren Lipid Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging and Contrast-enhanced Magnetic Resonance Imaging
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: No sites listed yet
Study dates: 12 Dec 2012to 5 Dec 2013
Phase: Phase 1
Are there results?: None posted in the registry

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

Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma
Be medically stable
If a female of child-bearing potential, must have a negative pregnancy test
Have signed Informed Consent to participate in the study

Who cannot join

Females who are pregnant or nursing
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
Patients on life support or in a critical care unit
Patients with unstable occlusive disease (eg, crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)

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Patients with recent cerebral hemorrhage
Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Patients with known hypersensitivity to perflutren
Patients who have received any contrast medium (x-ray, MRI, computed tomography [CT], or ultrasound [US]) in the 24 hours prior to the research US exam
Patients with cardiac shunts
Patients with congenital heart defects
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with respiratory distress syndrome

About this study

Official title: Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads

This pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer.

Read the detailed description

PRIMARY OBJECTIVES:

Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads.

SECONDARY OBJECTIVES:

Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.

Conditions: Hepatocellular Carcinoma
Being tested: Perflutren Lipid Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging, Contrast-enhanced Magnetic Resonance Imaging
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Perflutren Lipid MicrospheresDrug
Also called Definity
Given IV
Dynamic Contrast-Enhanced Ultrasound ImagingDevice
Undergo contrast-enhanced ultrasound imaging
Contrast-enhanced Magnetic Resonance ImagingDevice
Also called Contrast-enhanced MRI
Undergo contrast-enhanced Magnetic Resonance Imaging

Study groups in NCT03045497
Study group	Role	What they receive
Diagnostic (contrast-enhanced ultrasound)	Experimental	Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care. Receives: Drug: Perflutren Lipid Microspheres; Device: Dynamic Contrast-Enhanced Ultrasound Imaging; Device: Contrast-enhanced Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated.
Measured: Up to 1 month after transarterial chemoembolization

Secondary outcomes (4)

Change in quantitative blood flow parameters
Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.
Measured: Baseline to up to 1 month after transarterial chemoembolization
Quantitative parameters of tumor vascularity
Measured: Baseline to up to 1 month after transarterial chemoembolization
Changes in perfusion
Measured: Baseline to up to 1 month after transarterial chemoembolization
Changes in contrast fill time
Measured: Baseline to up to 1 month after transarterial chemoembolization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20125 Dec 2013

First posted7 Feb 2017 (estimated)
Study start12 Dec 2012
Primary completion5 Dec 2013
Study completion5 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatocellular CarcinomaStudies 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 1
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03045497
Sponsor's protocol ID: 12D.614
Other IDs: JT 2999
Status last verified: May 2025
First submitted: 31 Jan 2017
Last updated: 2 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

All Hepatocellular Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
ClinicalTrials.gov ID: NCT03045497
Acronym / sponsor ID: 12D.614
Conditions: Hepatocellular Carcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Study start: 12 Dec 2012 (actual)
Primary completion: 5 Dec 2013 (actual)
Study completion: 5 Dec 2013 (actual)
First posted: 7 Feb 2017 (estimated)
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.

Detailed description

PRIMARY OBJECTIVES:

Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads.

SECONDARY OBJECTIVES:

Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (contrast-enhanced ultrasound)	Experimental	Drug: Perflutren Lipid Microspheres, Device: Dynamic Contrast-Enhanced Ultrasound Imaging, Device: Contrast-enhanced Magnetic Resonance ImagingPatients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Be scheduled for a transarterial chemoembolization using drug eluting beads for treatment of hepatocellular carcinoma
Be medically stable
If a female of child-bearing potential, must have a negative pregnancy test
Have signed Informed Consent to participate in the study

Key exclusion criteria (15 listed)

Females who are pregnant or nursing
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
Patients with recent cerebral hemorrhage
Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination

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
Perflutren Lipid MicrospheresAlso: DefinityGiven IV	Drug	Diagnostic (contrast-enhanced ultrasound)
Dynamic Contrast-Enhanced Ultrasound ImagingUndergo contrast-enhanced ultrasound imaging	Device	Diagnostic (contrast-enhanced ultrasound)
Contrast-enhanced Magnetic Resonance ImagingAlso: Contrast-enhanced MRIUndergo contrast-enhanced Magnetic Resonance Imaging	Device	Diagnostic (contrast-enhanced ultrasound)

Primary outcome

Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
Time frame: Up to 1 month after transarterial chemoembolization
Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated.

4 secondary outcomes

Change in quantitative blood flow parameters
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Quantitative parameters of tumor vascularity
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Changes in perfusion
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Changes in contrast fill time
Time frame: Baseline to up to 1 month after transarterial chemoembolization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Sidney Kimmel Cancer CenterLink provided by the sponsor.
Thomas Jefferson University HospitalLink provided by the sponsor.

Related trials for Hepatocellular Carcinoma

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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. This study is not recruiting at the moment.

Flemming Forsberg, PhD principal investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 15 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: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads (time frame: Up to 1 month after transarterial chemoembolization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03045497.

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 2 May 2025.