Clinical trial NCT03045497: Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Liver Cancer Receiving Transarterial Chemoembolization With Drug Eluting Beads
Official title: Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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

Primary outcomes:
measure: Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads
timeFrame: Up to 1 month after transarterial chemoembolization
Secondary outcomes:
measure: Change in quantitative blood flow parameters
timeFrame: Baseline to up to 1 month after transarterial chemoembolization
measure: Quantitative parameters of tumor vascularity
timeFrame: Baseline to up to 1 month after transarterial chemoembolization
measure: Changes in perfusion
timeFrame: Baseline to up to 1 month after transarterial chemoembolization
measure: Changes in contrast fill time
timeFrame: Baseline to up to 1 month after transarterial chemoembolization
Other outcomes:
Locations:
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: Flemming Forsberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: