Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-03 @ 5:10 PM
Study NCT ID:
NCT06473103
Status:
RECRUITING
Last Update Posted:
2025-03-17
First Post:
2024-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative agreement between clear margin distance on TPFM and conventional paraffin embedded histology', 'timeFrame': 'Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery', 'description': 'The distance from the furthest extent of the tumor to the nearest surgical margin will be measured on both TPFM and conventional paraffin histology and the numerical difference calculated.'}], 'secondaryOutcomes': [{'measure': 'Overall agreement on margin status', 'timeFrame': 'Upon receipt of postoperative pathology slides, typically 2-4 weeks post surgery', 'description': 'The status of margins (positive/negative) will be compared'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Basal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '36069886', 'type': 'BACKGROUND', 'citation': 'Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during standard local excision.', 'detailedDescription': 'This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care permanent sections for final margin confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation on permanent sections, thus all patients will receive standard of care confirmation following experimental imaging. Individual excisions from consenting patients will be selected, fluorescently labeled and the distance to inked margins measured with TPFM. Following imaging, specimens will be submitted for paraffin processing as per normal procedure and the resulting slides scanned. The distance to the inked margin will be measured on the permanent sections and compared to TPFM to determine accuracy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing treatment for basal cell carcinoma without Mohs surgery at the performance site\n* Able to read and understand consent form\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06473103', 'briefTitle': 'Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Investigation of Standard Excision Surgical Margins Using Two Photon Fluorescence Microscopy', 'orgStudyIdInfo': {'id': 'STUDY00009521'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPFM imaging of surgical margins', 'description': 'Excised tissue will be imaged with TPFM to determine the distance from tumor to nearest inked margin.', 'interventionNames': ['Device: Two photon fluorescence microscopy imaging']}], 'interventions': [{'name': 'Two photon fluorescence microscopy imaging', 'type': 'DEVICE', 'description': 'Excised tissues will be imaged with two photon fluorescence microscopy prior to submission for histological processing.', 'armGroupLabels': ['TPFM imaging of surgical margins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14654', 'city': 'Victor', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sherrif Ibrahim, MD-Ph.D.', 'role': 'CONTACT', 'email': 'dr.ibrahim@rochesterdermsurgery.com', 'phone': '585-222-1400'}], 'facility': 'Rochester Dermatologic Surgery', 'geoPoint': {'lat': 42.98256, 'lon': -77.40888}}], 'centralContacts': [{'name': 'Michael Giacomelli, Ph.D.', 'role': 'CONTACT', 'email': 'mgiacome@ur.rochester.edu', 'phone': '5852766260'}], 'overallOfficials': [{'name': 'Michael Giacomelli', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rochester Dermatologic Surgery', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Giacomelli', 'investigatorAffiliation': 'University of Rochester'}}}}