Mass of Soft TissueNCT03171857
Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses
An observational study of Mass of Soft Tissue, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mass of Soft Tissue
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients in different age groups with superficial soft tissue lesions
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Doppler Ultrasound in Evaluation of Superficial Soft Tissue Masses
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.
Read the 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.
- Conditions
- Mass of Soft Tissue
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients diagnosed as superficial soft tissue lesions by doppler ultrasound.
Effectiveness of Doppler ultrasound in evaluation of superficial soft tissue masses in comparison with histopathological data of these lesions.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mass of Soft TissueStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Samir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171857
- Sponsor's protocol ID
- DUSSSTM
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brkljacic B, Kuzmic AC, Dmitrovic R, Rados M, Vidjak V. Doppler sonographic renal resistance index and resistance index ratio in children and adolescents with unilateral hydronephrosis. Eur Radiol. 2002 Nov;12(11):2747-51. doi: 10.1007/s00330-001-1259-0. Epub 2002 Feb 2.
PubMed 12386768Taurino M, Rizzo L, Stella N, Mastroddi M, Conteduca F, Maggiore C, Faraglia V. Doppler ultrasonography and exercise testing in diagnosing a popliteal artery adventitial cyst. Cardiovasc Ultrasound. 2009 May 27;7:23. doi: 10.1186/1476-7120-7-23.
PubMed 19473494Toprak H, Kilic E, Serter A, Kocakoc E, Ozgocmen S. Doppler US in rheumatic diseases with special emphasis on rheumatoid arthritis and spondyloarthritis. Diagn Interv Radiol. 2014 Jan-Feb;20(1):72-7. doi: 10.5152/dir.2013.13127.
PubMed 23996840
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Doppler Ultrasound in Evaluation of Superficial Soft Tissue Masses
- ClinicalTrials.gov ID
- NCT03171857
- Acronym / sponsor ID
- DUSSSTM
- Conditions
- Mass of Soft Tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 31 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients in different age groups with superficial soft tissue lesions
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Background: PubMed 12386768Brkljacic B, Kuzmic AC, Dmitrovic R, Rados M, Vidjak V. Doppler sonographic renal resistance index and resistance index ratio in children and adolescents with unilateral hydronephrosis. Eur Radiol. 2002 Nov;12(11):2747-51. doi: 10.1007/s00330-001-1259-0. Epub 2002 Feb 2.
- Background: PubMed 19473494Taurino M, Rizzo L, Stella N, Mastroddi M, Conteduca F, Maggiore C, Faraglia V. Doppler ultrasonography and exercise testing in diagnosing a popliteal artery adventitial cyst. Cardiovasc Ultrasound. 2009 May 27;7:23. doi: 10.1186/1476-7120-7-23.
- Background: PubMed 23996840Toprak H, Kilic E, Serter A, Kocakoc E, Ozgocmen S. Doppler US in rheumatic diseases with special emphasis on rheumatoid arthritis and spondyloarthritis. Diagn Interv Radiol. 2014 Jan-Feb;20(1):72-7. doi: 10.5152/dir.2013.13127.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Mass of Soft Tissue, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hasan Ibrahim Megalli, Professor (01006209584, hasanibrahim48@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients diagnosed as superficial soft tissue lesions by doppler ultrasound. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03171857, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.