Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas
PRIMARY OBJECTIVES:
I. To investigate whether two different radiologists can reliably interpret the following
quantitative criteria regarding the maximally enhancing portion of a soft tissue sarcoma
(STS), on sequential contrast-enhanced ultrasound (CEUS) exams performed before, during, and
after neoadjuvant chemotherapy (NAC): change in peak enhancement (decibels), change in slope
of enhancement curve, and change in area under the curve.
II. To evaluate CEUS as a potential early response assessment biomarker by comparing the
CEUS rating result to computed tomography (CT)/magnetic resonance imaging (MRI) rating
results. (Exploratory) III. To examine the agreement between CEUS versus CT/MRI determined
treatment response within each radiologist rater. (Exploratory) IV. To examine the agreement
between CEUS versus CT/MRI determined treatment response based on the consensus rating
result from the two radiologist raters. (Exploratory) V. To explore potential quantitative
biomarker from all possible parameters that can be extracted from CEUS data for assessing an
early treatment response to neoadjuvant therapy (NAT) in sarcoma using receiver operating
characteristic (ROC) curve when predicting radiologists rated binary outcome: responders
versus non-responders. (Exploratory) VI. To collect preliminary data for shear wave
elastography (SWE) in the same patient population. (Exploratory)
OUTLINE:
Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant
therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery).
After completion of study, patients are followed up at 24 hours.
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