Imaging of Soft Tissues

Soft Tissue Injury Clinical Trial

Official title:

Elasticity Imaging of Soft Tissues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00796094
• Other study ID #: HUM 20943
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: November 8, 2016
• Start date: December 2008
• Est. completion date: February 2009

Study information

• Verified date: November 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the potential importance of tissue elasticity in the assessment of soft tissues including muscles, tendons and ligaments and other soft tissue structures.

The evaluation of tissue elasticity (easily stretched or moveable) may assist in assessment of various soft tissue structures, such as fatty atrophy of muscles, tendon/ligamentous injury and healing and other soft tissue structures.

Description:

This is a prospective study that will recruit males and females 18 years of age and older who present to the department for a clinically indicated ultrasound of a superficial soft tissue abnormality with prior or following MRI / CT assessment ordered for clinical purposes.

The elasticity properties of tissues depend on their molecular building blocks and on the organization of these blocks. Injuries, disease etc are known to be associated with changes in tissue elasticity. Little research has been done on the potential of sonoelastographic (elasticity ultrasound imaging) assessment of normal, injured or healing muscles, tendons or ligaments.

Elasticity changes in muscle, ligaments and tendons following injury may have implication on the choice of treatment and help in determine how the length of time needed to heal from an injury.

Stiffness/elasticity of the tissue can be assessed by mechanical excitation with measurement of resultant tissue motion. Reconstruction of the elastic deformability (strain imaging) in real time ultrasound is known as sonoelastography.

Elasticity ultrasound imaging will be performed on the area being evaluated clinically.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who present for a clinically ordered ultrasound for evaluation of a soft tissue abnormality.

Exclusion Criteria:

• Women who are pregnant

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Soft Tissue Injuries
• Soft Tissue Injury

Intervention

Other:
• Ultrasound examination
Sonoelastrography is an ultrasound examination that can determine the elasticity of soft tissue. This examination takes approximately 10 minutes to complete.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the potential importance of Sonoelastography in evaluating tissue injury or abnormalities of soft tissues.		hours	No