The Value of Ultrasound Elastography for Differentiating Benign and Malignant Superficial Soft Tissue Masses
1 other identifier
observational
56
0 countries
N/A
Brief Summary
Ultrasonography has the advantages of being widely available, cost-effective, and allowing real-time dynamic examinations. Additionally, it is less time-consuming than magnetic resonance imaging (MRI) \[1,2\]. Recently developed ultrasound elastography techniques provide valuable information about intrinsic tissue properties by evaluating tissue elasticity, which may contribute to the diagnosis \[3,4\]. Ultrasound elastography can quantify and qualify tissue elasticity and add important information to the findings obtained by conventional ultrasonography \[3,5-7\]. Superficial soft tissue masses frequently occur and primarily manifest as benign lesions (including lipoma and hemangioma) that typically do not require treatment. Although malignant masses are rare, prompt surgical resections are required following the confirmation of a diagnosis (8). Therefore, differentiating between benign and malignant masses is important to prevent delays in the treatment of the malignant masses and avoid unnecessary surgical treatments for the benign masses (9). As the most effective method, pathological diagnosis is typically obtained from a needle biopsy. However, it is an invasive maneuver that is uncomfortable for patients and impractical for all types of soft tissue masses (10). Ultrasound is the primary examination method for superficial soft tissue masses to confirm their size, location, and the association between the masses and the surrounding structures. Through observations of the borders of the tissue masses, internal echo characteristics, and internal blood flow signals, ultrasounds may provide a preliminary diagnosis that is inaccurate (11). Stiffness of the tissue structures may be accessed using ultrasound elastography (UE) (12), which is an effective tool for differentiating malignant and benign masses (13). The stiffness of a malignant tumor is typically higher compared with a benign tumor. Previously, the differential diagnosis was primarily based on palpations by the physicians, which was indirect and could be limited in patients with obesity, mass sizes and depths, and physicians' experiences.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Feb 2023
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2023
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJanuary 20, 2023
January 1, 2023
11 months
January 11, 2023
January 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
to investigate the value of ultrasound Elastography for differentiating benign and malignant superficial soft tissue masses .
baseline
Interventions
For each lesion, ultrasound Elastography would be performed using a Linear probe ;
Eligibility Criteria
This study will analyze patients who receive care at our institution patients with soft tissue masses. We retrospectively investigate patients' medical records, ultrasonographic exams, and histopathology reports
You may qualify if:
- patients with superficial masses
You may not qualify if:
- inflammatory lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Yeoh HJ, Kim TY, Ryu JA. The feasibility of shear wave elastography for diagnosing superficial benign soft tissue masses. Ultrasonography. 2019 Jan;38(1):37-43. doi: 10.14366/usg.17059. Epub 2018 Jan 19.
PMID: 29580047BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assuit
Study Record Dates
First Submitted
January 11, 2023
First Posted
January 20, 2023
Study Start
February 1, 2023
Primary Completion
December 30, 2023
Study Completion
December 30, 2024
Last Updated
January 20, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share