Clinical trial

Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas

Name
11S-14-1
Description
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.
Trial arms
Trial start
2014-12-24
Estimated PCD
2024-01-19
Trial end
2024-01-19
Status
Completed
Phase
Early phase I
Treatment
Real-Time CEUS
Undergo real-time CEUS
Arms:
Real-time CEUS and SWE
SWE
Undergo SWE
Arms:
Real-time CEUS and SWE
Other names:
Shear Wave Elastography
Definity Suspension for Injection
Participant will receive contrast agent by intravenous administration
Arms:
Real-time CEUS and SWE
Other names:
Perflutren Lipid Microsphere
Philips Shear Wave Elastography
Type of equipment used for SWE
Arms:
Real-time CEUS and SWE
Other names:
Shear Wave Elagstography
Size
25
Primary endpoint
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient
Up to 9 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}
Updated at
2024-01-23

1 organization

1 product

3 indications

Product
Definity
Indication
Bone Sarcoma
Indication
Sarcoma