Real-Time Contrast-Enhanced Ultrasonography and Shear Wave Elastography in Predicting Treatment Response in Patients With Soft Tissue Sarcoma

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.

Inclusion Criteria:

- Patients with biopsy and/or conventional imaging (CT/MRI) proven STS or bone sarcoma
with a measurable soft tissue component; these include patients with extremity,
retroperitoneal, chest wall, or head and neck primary sarcomas

- Patients who are potential candidates to receive neoadjuvant therapy with either
chemotherapy alone, radiation alone, immunotherapy alone or combined treatment with
any of these modalities. If on therapy, patients in whom a new treatment protocol or
modality is being considered.

- Patients competent to sign study specific informed consent

- Patients willing to comply with protocol requirements

Exclusion Criteria:

- Patients who are pregnant

- Patients who have a known cardiac shunt or pulmonary hypertension

- Patients with any known hypersensitivity to perflutren agent

- Patients who cannot consent for themselves