Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas
Description
Brief Summary
This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave
elastography in predicting treatment response in patients with soft tissue sarcomas.
Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make
pictures of the body without using radiation (x-rays). Real-time contrast-enhanced
ultrasonography and shear wave elastography may help measure a patient's response to
treatment given before surgery in patients with soft tissue sarcoma.
Detailed Description
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.
Phase
N/AInclusion and Exclusion 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
- 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
Sites
Please contact Akshay Bhavsar to learn more about where you can participate in this trial. Please use the contact form on the right side.
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