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

NCT ID: NCT02384473

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-24
• Study Completion Date: 2024-01-19

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.

Conditions

Adult Soft Tissue Sarcoma; Bone Sarcoma; Retroperitoneal Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Real-time CEUS and 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).

Group Type: EXPERIMENTAL

Real-Time CEUS

Intervention Type: PROCEDURE

Undergo real-time CEUS

SWE

Intervention Type: PROCEDURE

Undergo SWE

Definity Suspension for Injection

Intervention Type: DRUG

Participant will receive contrast agent by intravenous administration

Philips Shear Wave Elastography

Intervention Type: DEVICE

Type of equipment used for SWE

Interventions

Real-Time CEUS

Undergo real-time CEUS

Intervention Type: PROCEDURE

SWE

Undergo SWE

Intervention Type: PROCEDURE

Definity Suspension for Injection

Participant will receive contrast agent by intravenous administration

Intervention Type: DRUG

Philips Shear Wave Elastography

Type of equipment used for SWE

Intervention Type: DEVICE

Other Intervention Names

Shear Wave Elastography; Perflutren Lipid Microsphere; Shear Wave Elagstography

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mittul Gulati

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2014-02579

Identifier Type: REGISTRY

Identifier Source: secondary_id

HS-14-00792

Identifier Type: -

Identifier Source: secondary_id

11S-14-1

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014089

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11S-14-1

Identifier Type: -

Identifier Source: org_study_id