Validation of Ultra Sound (US) Elastography

Soft Tissue Lesions Clinical Trial

— USE  

Official title:

Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02773264
• Other study ID #: idr-us-001
• Status: Recruiting
• Start date: March 2016
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: University of Zurich
• Contact: Thomas Frauenfelder, PD MD
• Phone: 0041442551111
• Email: thomas.frauenfelder[@]usz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Description:

The investigators propose UltraSound Elastography as an imaging method which allows for a better evaluation of soft tissue and organ lesions compared to the conventional US modalities used nowadays in the dayly clinical routine.

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient scheduled for clinically indicated conventional Ultrasound examination

Exclusion Criteria:

• Age < 18 years

Related Conditions & MeSH terms

• Soft Tissue Lesions

Intervention

Device:
• Ultrasound
Ultrasound Elastography of soft tissue and organ lesions

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich - Diagnostic Radiology	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Inferiority to conventional Ultrasound (conv. US)	Value of US Elastography compared to conventional US	when scheduled for conv. US, 30minutes
Secondary	Superiority to conventional Ultrasound (conv. US)	Value of US Elastography compared to conventional US	when scheduled for conv. US, 30minutes

External Links

•   Elastography in pancreatic solid tumours diagnoses.