NCT05692141

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 11, 2023

Last Update Submit

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

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Aliaa Sayed, Resident

CONTACT

Gehan Sayed, prof

CONTACT

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