Perflutren Lipid Microspheres
DrugGiven IV
Other names: Definity
NCT Number: NCT03045497
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Given IV
Other names: Definity
Undergo contrast-enhanced ultrasound imaging
Undergo contrast-enhanced Magnetic Resonance Imaging
Other names: Contrast-enhanced MRI
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.
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established.
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Time frame: Baseline to up to 1 month after transarterial chemoembolization
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Other
Contrast-Enhanced Ultrasound for the Evaluation of Transarterial Chemoembolization With Drug Eluting Beads
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