An Early Phase 1 interventional study of Real-Time CEUS and SWE in Adult Soft Tissue Sarcoma, Bone Sarcoma and Retroperitoneal Sarcoma, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by University of Southern California · Early Phase 1, Interventional, and Diagnostic
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.
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.
1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.
This study's enrollment of 25 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
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).
Procedure: Real-Time CEUS · Procedure: SWE · Drug: Definity Suspension for Injection · Device: Philips Shear Wave Elastography
Undergo real-time CEUS
Undergo SWE
Also known as: Shear Wave Elastography
Participant will receive contrast agent by intravenous administration
Also known as: Perflutren Lipid Microsphere
Type of equipment used for SWE
Also known as: Shear Wave Elagstography
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient
Kappa coefficient will be used. Reviewer 1 will first rate the treatment response followed by reviewer 2. Reviewer 2 will be blinded to the rating of reviewer 1.
Time frame: Up to 9 weeks
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University of Southern California