Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-01-09 @ 9:58 AM
Study NCT ID:
NCT03457766
Status:
COMPLETED
Last Update Posted:
2022-11-25
First Post:
2018-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presurgical Evaluation of Skin Cancers Using HIFU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Using high frequency ultrasound in identification of safety margins of skin cancers'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2018-02-24', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete excision of nonmelanoma skin cancers', 'timeFrame': 'Baseline', 'description': 'Determination the accuracy of HIFU to assess the margins of skin lesions and its safety margins to ensure complete elimination of lesions with maximum preservation of function and aesthetics'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Cancer, Non-Melanoma']}, 'referencesModule': {'references': [{'pmid': '19043850', 'type': 'BACKGROUND', 'citation': 'Proksch E, Brandner JM, Jensen JM. The skin: an indispensable barrier. Exp Dermatol. 2008 Dec;17(12):1063-72. doi: 10.1111/j.1600-0625.2008.00786.x.'}, {'pmid': '24054424', 'type': 'BACKGROUND', 'citation': 'Eggermont AM, Spatz A, Robert C. Cutaneous melanoma. Lancet. 2014 Mar 1;383(9919):816-27. doi: 10.1016/S0140-6736(13)60802-8. Epub 2013 Sep 19.'}, {'pmid': '20171403', 'type': 'BACKGROUND', 'citation': 'Madan V, Lear JT, Szeimies RM. Non-melanoma skin cancer. Lancet. 2010 Feb 20;375(9715):673-85. doi: 10.1016/S0140-6736(09)61196-X.'}, {'pmid': '22285673', 'type': 'BACKGROUND', 'citation': 'Kleinerman R, Whang TB, Bard RL, Marmur ES. Ultrasound in dermatology: principles and applications. J Am Acad Dermatol. 2012 Sep;67(3):478-87. doi: 10.1016/j.jaad.2011.12.016. Epub 2012 Jan 30.'}, {'pmid': '18812268', 'type': 'BACKGROUND', 'citation': 'Bobadilla F, Wortsman X, Munoz C, Segovia L, Espinoza M, Jemec GB. Pre-surgical high resolution ultrasound of facial basal cell carcinoma: correlation with histology. Cancer Imaging. 2008 Sep 22;8(1):163-72. doi: 10.1102/1470-7330.2008.0026.'}, {'pmid': '11966724', 'type': 'BACKGROUND', 'citation': 'Diepgen TL, Mahler V. The epidemiology of skin cancer. Br J Dermatol. 2002 Apr;146 Suppl 61:1-6. doi: 10.1046/j.1365-2133.146.s61.2.x.'}, {'pmid': '16490846', 'type': 'BACKGROUND', 'citation': 'Essers BA, Dirksen CD, Nieman FH, Smeets NW, Krekels GA, Prins MH, Neumann HA. Cost-effectiveness of Mohs Micrographic Surgery vs Surgical Excision for Basal Cell Carcinoma of the Face. Arch Dermatol. 2006 Feb;142(2):187-94. doi: 10.1001/archderm.142.2.187.'}, {'pmid': '17101476', 'type': 'BACKGROUND', 'citation': 'Ansarin H, Daliri M, Soltani-Arabshahi R. Expression of p53 in aggressive and non-aggressive histologic variants of basal cell carcinoma. Eur J Dermatol. 2006 Sep-Oct;16(5):543-7.'}]}, 'descriptionModule': {'briefSummary': '1. To ensure complete elimination of lesions with maximum preservation of function and aesthetics.\n2. To elaborate the Ultrasonographic features of skin cancers.\n3. To determine the accuracy of HIFU to assess the margins of skin lesions and its safety margins by histopathiological examination..\n4. To follow up the patient postoperatively for incomplete excision or recurrence by clinical and HIFU examination.', 'detailedDescription': 'The skin is the most superficial and largest body organ, due to its function as a surface covering for the body, enables the performance of noninvasive diagnostic and investigative procedures.\n\nOf all the tumors that affect humans, non-melanoma cutaneous cancer is the most common e.g. basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).\n\nTechniques such as high frequency ultrasound (HFUS) enable the real-time study of cutaneous lesions, making them excellent pre-operative tools varying considerably in their penetration, resolution, and applicability.\n\nHigh frequency ultrasound has been used in dermatology since the 1970s, ultrasonography is a painless non-radioactive imaging diagnostic method based on the reflection of sound waves through body tissues.\n\nHigh frequency ultrasound allows for the delimiting of the margins of the neoplasia, due to the difference in echogenicity between the hypoechoic tumoral area and the hyperechoic perilesional area.\n\nHigh frequency ultrasound examination of each lesion should consist of:\n\n1. A morphologic study analyzing the structural sonographic pattern and margins;\n2. the measurement of the largest transverse diameter and thickness;\n3. Color Doppler USG for perilesional vessels ; and\n4. in cases suspicious for malignancy, the surrounding areas are scanned for locoregional metastasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 30 \\& 80 years.\n* Lesions clinically apparent locally malignant, or malignant.\n* Lesions with or without visible ulcerations.\n\nExclusion Criteria:\n\n* Surgeon unable to visualize tumor on clinical examination.\n* Patients unfit for surgery.'}, 'identificationModule': {'nctId': 'NCT03457766', 'briefTitle': 'Presurgical Evaluation of Skin Cancers Using HIFU', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Presurgical Evaluation of Nonmelanoma Skin Cancers Using High Frequency Ultrasound', 'orgStudyIdInfo': {'id': 'HIFU in skin cancers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with skin lesions', 'description': 'Using HIFU in identification of safety margins of lesions clinically apparent locally malignant, or malignant', 'interventionNames': ['Device: HIFU']}], 'interventions': [{'name': 'HIFU', 'type': 'DEVICE', 'otherNames': ['Esaota MyLabSeven'], 'description': 'Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency', 'armGroupLabels': ['Patients with skin lesions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mostafa AH El-Sonbaty, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'George Gamil Gergis', 'investigatorAffiliation': 'Assiut University'}}}}