Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT01771718
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'high-resolution images of skin', 'timeFrame': 'up to 12 months', 'description': 'The complementary imaging modalities (MPM, MI) will provide insights into a better understanding of the relationship between microscopic and macroscopic properties of the skin.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Lesion']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features.', 'detailedDescription': 'This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) and a MPM imaging system developed at BLI: Fast Large Area Multiphoton Exoscope (FLAME) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies.\n\nAny biopsies will be performed by the health care provider as a standard of care procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from University of California Irvine Medical Clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female all age groups\n* Ability to understand and carry out subject instructions\n\nExclusion Criteria:\n\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT01771718', 'briefTitle': 'Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Non-invasive Skin Imaging Using Multiphoton Microscopy', 'orgStudyIdInfo': {'id': '20118494'}, 'secondaryIdInfos': [{'id': 'R01EB026705', 'link': 'https://reporter.nih.gov/quickSearch/R01EB026705', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Human skin', 'description': 'Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure.', 'interventionNames': ['Device: Multiphoton microscopy-based tomograph.']}], 'interventions': [{'name': 'Multiphoton microscopy-based tomograph.', 'type': 'DEVICE', 'description': 'non-invasive optical biopsy', 'armGroupLabels': ['Human skin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92612', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Hanna Kim', 'role': 'CONTACT', 'email': 'hhkim3@uci.edu', 'phone': '949-824-2251'}, {'name': 'Kristen Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mihaela Balu, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth Linden, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Beckman Laser Institute Medical Clinic', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'centralContacts': [{'name': 'Hanna Kim', 'role': 'CONTACT', 'email': 'hhkim3@uci.edu', 'phone': '949-824-2251'}, {'name': 'Mihaela Balu, PhD', 'role': 'CONTACT', 'email': 'mbalu@uci.edu'}], 'overallOfficials': [{'name': 'Kristen Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute, UCI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair, Department of Dermatology', 'investigatorFullName': 'Kristen Kelly', 'investigatorAffiliation': 'University of California, Irvine'}}}}