Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 7:59 PM
Study NCT ID:
NCT01118832
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2010-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2010-05-05', 'studyFirstSubmitQcDate': '2010-05-06', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ability to Detect of the melanoma lesions', 'timeFrame': 'up to 2 years', 'description': 'Using activated cooling methods we are measuring skin surface temperature recovery of specific lesions and comparing them to biopsy results of the lesions in question.'}], 'secondaryOutcomes': [{'measure': 'Measurement of thermal signatures of benign cutaneous lesions', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Thermography'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'C HERMAN, THREE-DIMENSIONAL THERMAL IMAGING FOR THE DETECTION OF SKIN LESIONS AND OTHER NATURAL AND ABNORMAL CONDITIONS - WO Patent WO/2012/009,359, 2012'}, {'pmid': '23204850', 'type': 'RESULT', 'citation': 'Herman C. Emerging technologies for the detection of melanoma: achieving better outcomes. Clin Cosmet Investig Dermatol. 2012;5:195-212. doi: 10.2147/CCID.S27902. Epub 2012 Nov 12.'}], 'seeAlsoLinks': [{'url': 'http://www.jove.com/video/2679/quantitative-visualization-detection-skin-cancer-using-dynamic', 'label': 'Video article describing the melanoma scanner'}, {'url': 'http://www.dovepress.com/emerging-technologies-for-the-detection-of-melanoma-achieving-better-o-peer-reviewed-article-CCID', 'label': 'Review article discussing emerging technologies for the detection of melanoma'}, {'url': 'http://releases.jhu.edu/2010/02/26/scanning-for-skin-cancer-infrared-system-looks-for-deadly-melanoma/', 'label': 'Johns Hopkins News release about the infrared scanner for detection of skin cancer'}]}, 'descriptionModule': {'briefSummary': 'A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions and melanoma is developed. Goals include evaluation of the utility of high-resolution infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the identification of high-risk lesions and melanomas.', 'detailedDescription': 'This study uses a specific skin protocol to cool the skin and then measures the cutaneous thermal recovery to uniquely identify lesions that may be cancerous. Using computer models, the thermal signature is used to determine the size and shape of the lesions in question. In particular, this study seeks to add quantification analysis of high resolution thermal images of melanoma lesions to provide accurate early diagnostic capability with specific detail regarding size, shape and depth of the lesions. This information will be compared to biopsy results and surgical resection results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subject population will be identified in the Department of Dermatology Pigmented Lesion Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only comprise those requesting a cutaneous pigmented lesion removed or patients that are examined and found to have a pigmented lesion that is suspicious for malignancy at the time of their visit, and thus recommended to have a skin biopsy for diagnosis following the standard of care', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients seen in the high-risk pigmented lesion clinic, who posses a pigmented lesion with a clinical indication for biopsy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01118832', 'briefTitle': 'Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi', 'orgStudyIdInfo': {'id': 'J0868'}, 'secondaryIdInfos': [{'id': 'R01CA161265-02', 'link': 'https://reporter.nih.gov/quickSearch/R01CA161265-02', 'type': 'NIH'}, {'id': 'NA_00016040', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Cila Herman, Dr-Ing.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}