Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-25 @ 4:36 PM
Study NCT ID:
NCT00434057
Status:
COMPLETED
Last Update Posted:
2012-02-14
First Post:
2007-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Pigmented Skin Lesions With MelaFind(R) System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adrian@eosciences.com', 'phone': '(914)591-3783', 'title': 'Joanna Adrian / Director, Clinical Operations and Medical Affairs', 'phoneExt': '732', 'organization': 'Electro-Optical Sciences, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Biopsied Pigmented Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto', 'otherNumAtRisk': 1383, 'otherNumAffected': 0, 'seriousNumAtRisk': 1383, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity and Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1257', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Biopsied Pigmented Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto'}], 'classes': [{'title': 'MelaFind sensitivity to melanoma', 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '100'}]}]}, {'title': 'MelaFind specificity for melanoma', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '12.9'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'Sensitivity to melanoma', 'ciPctValue': '95', 'paramValue': '98', 'ciLowerLimit': '95.1', 'ciUpperLimit': '100', 'estimateComment': 'Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of "Melanoma can not be ruled out" or "Not melanoma," which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas.', 'groupDescription': "MelaFind's sensitivity to cutaneous melanoma and 95% confidence intervals were determined.", 'statisticalMethod': 'exact mid-P', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG000'], 'groupDescription': 'Specificty of MelaFind and examining dermatologists on the same set of pigmented skin lesions.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Within 120 days of Data Lock', 'description': 'Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.', 'unitOfMeasure': 'Ratio * 100', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with eligible and evaluable lesions were used in analysis of primary outcome measures', 'anticipatedPostingDate': '2009-02'}, {'type': 'SECONDARY', 'title': 'Biopsy Ratio', 'paramType': 'NUMBER', 'timeFrame': 'Within 120 days of Data Lock', 'description': 'Number of lesions bioopsied to melanomas detected', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2009-12'}, {'type': 'SECONDARY', 'title': 'Exploratory Analyses', 'timeFrame': 'Within 365 days of Data Lock', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2010-02'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Biopsied Pigmented Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1383'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient withdrew from the study after signing the Informed Consent Form', 'groupId': 'FG000', 'numSubjects': '1382'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1383', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Biopsied Pigmented Skin Lesions', 'description': 'Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1056', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '271', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '18.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '745', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '638', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1383', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-10', 'studyFirstSubmitDate': '2007-02-08', 'resultsFirstSubmitDate': '2009-05-26', 'studyFirstSubmitQcDate': '2007-02-08', 'lastUpdatePostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-11-10', 'studyFirstPostDateStruct': {'date': '2007-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity', 'timeFrame': 'Within 120 days of Data Lock', 'description': 'Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.'}], 'secondaryOutcomes': [{'measure': 'Biopsy Ratio', 'timeFrame': 'Within 120 days of Data Lock', 'description': 'Number of lesions bioopsied to melanomas detected'}, {'measure': 'Exploratory Analyses', 'timeFrame': 'Within 365 days of Data Lock'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pigmented Skin Lesions', 'Dermatology', 'Skin Cancer', 'Melanoma', 'MelaFind'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '20956633', 'type': 'DERIVED', 'citation': 'Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M, Grichnik JM, Mihm M, Prieto VG, Googe P, King R, Toledano A, Kabelev N, Wojton M, Gutkowicz-Krusin D. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94. doi: 10.1001/archdermatol.2010.302. Epub 2010 Oct 18.'}], 'seeAlsoLinks': [{'url': 'http://www.eosciences.com', 'label': 'Sponsor Web Site'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The lesion is pigmented (i.e., melanin, keratin, blood)\n* Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion\n* The diameter of the pigmented area is between 2 and 22 millimeters\n* The lesion is accessible to the MelaFind hand-held imaging device\n* The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form\n\nExclusion Criteria:\n\n* The patient has a known allergy to isopropyl alcohol\n* The lesion has been previously biopsied, excised, or traumatized\n* The skin is not intact (e.g., open sores, ulcers, bleeding)\n* The lesion is within 1 cm of the eye\n* The lesion is on mucosal surfaces (e.g., lips, genitals)\n* The lesion is on palmar hands\n* The lesion is on plantar feet\n* The lesion is on or under nails\n* The lesion is located on or in an area of visible scarring\n* The lesion contains foreign matter (e.g., tattoo, splinter, marker)'}, 'identificationModule': {'nctId': 'NCT00434057', 'briefTitle': 'Evaluation of Pigmented Skin Lesions With MelaFind(R) System', 'organization': {'class': 'INDUSTRY', 'fullName': 'MELA Sciences, Inc.'}, 'officialTitle': 'Evaluation of Pigmented Skin Lesions With MelaFind(R) System', 'orgStudyIdInfo': {'id': '20061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Biopsied Pigmented Skin Lesions', 'description': 'Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto', 'interventionNames': ['Device: MelaFind(R)']}], 'interventions': [{'name': 'MelaFind(R)', 'type': 'DEVICE', 'otherNames': ['MF100', 'MelaFind Device System', 'MelaFind Device'], 'description': 'Biopsy ratio comparison', 'armGroupLabels': ['Biopsied Pigmented Skin Lesions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Skin and Cancer Associates', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '32317', 'city': 'Tallahassee', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology Associates of Tallahassee', 'geoPoint': {'lat': 30.43826, 'lon': -84.28073}}], 'overallOfficials': [{'name': 'Dina Gutkowicz-Krusin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Electro-Optical Sciences, Inc.'}, {'name': 'Joseph V Gulfo, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Electro-Optical Sciences, Inc.'}, {'name': 'Harold S Rabinovitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Skin and Cancer Associates'}, {'name': 'Armand B Cognetta, Jr, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Dermatology Associates of Tallahassee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MELA Sciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}