Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT03171857
Status:
UNKNOWN
Last Update Posted:
2017-05-31
First Post:
2017-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2017-05-28', 'studyFirstSubmitQcDate': '2017-05-30', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients diagnosed as superficial soft tissue lesions by doppler ultrasound.', 'timeFrame': '2 years', 'description': 'Effectiveness of Doppler ultrasound in evaluation of superficial soft tissue masses in comparison with histopathological data of these lesions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mass of Soft Tissue']}, 'referencesModule': {'references': [{'pmid': '12386768', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19473494', 'type': 'BACKGROUND', 'citation': 'Taurino 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.'}, {'pmid': '23996840', 'type': 'BACKGROUND', 'citation': 'Toprak 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nNowadays, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in different age groups with superficial soft tissue lesions\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT03171857', 'briefTitle': 'Doppler Ultrasound in Characterization of Superficial Soft Tissue Masses', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Doppler Ultrasound in Evaluation of Superficial Soft Tissue Masses', 'orgStudyIdInfo': {'id': 'DUSSSTM'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hasan Ibrahim Megalli, Professor', 'role': 'CONTACT', 'email': 'hasanibrahim48@yahoo.com', 'phone': '01006209584'}, {'name': 'Abeer Hussein Ali, Lecturer', 'role': 'CONTACT', 'email': 'abeeryaa@yahoo.com', 'phone': '01007078382'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Andrew Samir', 'investigatorAffiliation': 'Assiut University'}}}}