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Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses

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ClinicalTrials.gov Identifier: NCT03171857
Recruitment Status : Unknown
Verified May 2017 by Andrew Samir, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Samir, Assiut University

Tracking Information
First Submitted Date May 28, 2017
First Posted Date May 31, 2017
Last Update Posted Date May 31, 2017
Estimated Study Start Date June 1, 2017
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2017)
Patients diagnosed as superficial soft tissue lesions by doppler ultrasound. [ Time Frame: 2 years ]
Effectiveness of Doppler ultrasound in evaluation of superficial soft tissue masses in comparison with histopathological data of these lesions.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses
Official Title Role of Doppler Ultrasound in Evaluation of Superficial Soft Tissue Masses
Brief Summary A wide variety of superficial soft tissue masses may be seen in clinical practice. Superficial soft tissue masses can generally be categorized as mesenchymal tumors, skin appendage lesions, metastatic tumors, other tumors and tumor-like lesions, or inflammatory lesions. The investigators will use doppler ultrasound in evaluation of superficial soft tissue masses characterization.
Detailed Description

There are many examples for these benign superficial soft tissue lesions as lipoma, ganglion, Baker's cyst, giant cell tumor, lymphangioma, hernia, abscess, epidermoid cyst, hematoma, muscle rupture, glomus tumor, fibromatosis, lymphadenitis hemangioma, exostosis, fibroma, neurofibroma and schwannoma. Malignant lesions also could be seen as lymphoma, metastasis, osteogenic sarcoma, liposarcoma , leiomyosarcoma, rhabdomyosarcoma and synovial sarcoma.

Nowadays, High resolution ultrasound has a high sensitivity in detecting superficial soft tissue masses through the grey-scale grading that compose an image range from pure black at the weakest intensity to pure white at the strongest that can be used to evaluate its structure, some aspects of its function and to determine the nature of a mass lesion (cystic or solid) and with Doppler ultrasound which is an excellent imaging modality to determine the vascularity of superficial soft tissue masses that can be characterized in terms of their echogenicity, margin, shape, composition, acoustic transmission, size, the grading of color Doppler ultrasound , and resistive index in spectral Doppler as spectral Doppler will be applied in lesions with positive color flow signals.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients that have superficial soft tissue masses in different age groups that referred from the outpatient clinics of the general or orthopaedic surgery, Assiut University Hospital to the Diagnostic Radiology Department
Condition Mass of Soft Tissue
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 30, 2017)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients in different age groups with superficial soft tissue lesions

Exclusion Criteria:

  • If the patient undergo previous operations at the same mass that could change the criteria of that mass or if the mass is recurrent at the same site.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03171857
Other Study ID Numbers DUSSSTM
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Andrew Samir, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date May 2017