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

NCT02384473 | Completed Early Phase 1 DMC FDA Drug FDA Device

• 4 other identifiers: 11S-14-1NCI-2014-02579HS-14-00792P30CA014089
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Soft Tissue Sarcoma; Bone Sarcoma; Retroperitoneal Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 9 weeks

Study Arms (1)

Real-time CEUS and SWE

EXPERIMENTAL

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

Interventions

Real-Time CEUS PROCEDURE

Undergo real-time CEUS

Real-time CEUS and SWE

SWE PROCEDURE

Undergo SWE

Also known as: Shear Wave Elastography

Real-time CEUS and SWE

Definity Suspension for Injection DRUG

Participant will receive contrast agent by intravenous administration

Also known as: Perflutren Lipid Microsphere

Real-time CEUS and SWE

Philips Shear Wave Elastography DEVICE

Type of equipment used for SWE

Also known as: Shear Wave Elagstography

Real-time CEUS and SWE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Sarcoma; Bone Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mittul Gulati

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: March 10, 2015
• Study Start: December 24, 2014
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Locations

US (1)