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

Early Phase 1

Completed

• Conditions: Bone Sarcoma; Retroperitoneal Sarcoma; Adult Soft Tissue Sarcoma
• Interventions: Procedure: Real-Time CEUS; Procedure: SWE; Drug: Definity Suspension for Injection; Device: Philips Shear Wave Elastography

• Registration Number: NCT02384473
• Lead Sponsor: University of Southern California

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-12-24
• Study First Submitted: 2015-01-16
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-10
• Status Verified: 2024-01
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Real-time CEUS and SWE	SWE	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).
Real-time CEUS and SWE	Real-Time CEUS	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).
Real-time CEUS and SWE	Definity Suspension for Injection	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).
Real-time CEUS and SWE	Philips Shear Wave Elastography	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).

Primary Outcome Measures

Name	Time	Method
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient	Up to 9 weeks	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.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States