[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07182240":3,"trial-entities:NCT07182240":97,"trial-summary:NCT07182240":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":57,"minimum_age":58,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":71,"locations":74,"central_contacts":84,"overall_officials":90,"references":95,"see_also_links":96},"NCT07182240","I-3839125","Pilot Study of Line-Field Confocal Optical Coherence Tomography for Detection of Mohs Micrographic Surgery Margins of Basal Cell Carcinomas","RECRUITING","2027-06-22","2026-05","2026-06-01","2025-12-22","Roswell Park Cancer Institute","OTHER",false,"To assess the feasibility and provide information on the utility of noninvasive line field confocal optical coherence tomography (LC-OCT) for the presurgical assessment of Mohs micrographic surgery sites in patients undergoing removal of cutaneous basal cell carcinomas (BCC).",null,[18],"Basal Cell Carcinoma",[],"INTERVENTIONAL","DIAGNOSTIC",[23],"NA",{"count":25,"type":26},60,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","LC-OCT Imaging","handheld imaging device will take high resolution images of lesion",[33],"Noninvasive Imaging Procedue -Line-field optical coherence tomography(LC-OCT)",[35],{"measure":36,"description":37,"timeFrame":38},"Number of cases with fully evaluable images","cases were the image evaluator can assess the margins based on image quality","1.5 years",[40,43,47,51,54],{"measure":41,"description":42,"timeFrame":38},"Patient interest in study","Will be measured by documenting the number of patients offered study participation and the number choosing to participate in the study",{"measure":44,"description":45,"timeFrame":46},"Patients overall experience","Collect a 3-question questionnaire to document patients experience.","one office visit - immediately after imaging procedure",{"measure":48,"description":49,"timeFrame":50},"Determine LC-OCT imaging's impact on surgical workflow","Will be assessed by results of imaging assessment questionnaire given to surgeon","To be filled out immediately after finishing Mohs procedure",{"measure":52,"description":53,"timeFrame":38},"Accuracy of LC-OCT findings","Will be evaluated by Comparing LC-OCT findings with frozen section histopathological results",{"measure":55,"description":56,"timeFrame":38},"Accuracy of LC-OCT in detectng location of tumor","will be evaluated by comparing the location of the LC-OCT reported margin positivity to the Mohs map","ALL","18 Years",{"inclusion":60,"exclusion":65,"raw_text":70},[61,62,63,64],"Age ≥ 18 years","Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.","Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.","The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.",[66,67,68,69],"Known or reported allergy to mineral oil, the optical agent used during imaging.","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",". Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.","Unwilling or unable to follow protocol requirements","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must understand the investigational nature of this study and provide written consent prior to receiving any study-related procedure.\n* Participant must be clinically eligible for Mohs surgery as determined by their referring dermatologist and the Mohs surgeon.\n* The participant must have a BCC with superficial histology or a BCC with multiple histological features that also include superficial histology, which is appropriate for Mohs surgery.\n\nExclusion Criteria:\n\n* Known or reported allergy to mineral oil, the optical agent used during imaging.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* . Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo imaging procedure.\n* Unwilling or unable to follow protocol requirements",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":76,"status":7,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263","United States",{"lat":82,"lon":83},42.88645,-78.87837,[85],{"name":86,"role":87,"phone":88,"email":89},"Ask RPCI","CONTACT","1-800-767-9355","askrpc@Roswellpark.org",[91],{"name":92,"affiliation":93,"role":94},"Gyorgy Paragh, MD","Roswell Park","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[18],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study designed to enroll 60 participants. It is a pilot study, meaning it's an early look at the usefulness of the LC-OCT device.","completed","Pilot Study of LC-OCT for Basal Cell Carcinoma Margins","This study is testing a new handheld imaging device called Line-Field Confocal Optical Coherence Tomography (LC-OCT Imaging) to see how well it can help doctors check the edges of basal cell carcinomas (a common type of skin cancer) before Mohs micrographic surgery. Doctors want to see if this device can provide useful information for planning surgery. You may be able to join if you are 18 or older, understand the study, and are already scheduled for Mohs surgery for basal cell carcinoma. The main goal is to see how many cases result in clear, usable images from the device. The current status of this study is unclear, and it plans to enroll 60 participants.","The primary endpoint, which assesses the number of cases with fully evaluable images, is measured at 1.5 years.",114,"Participants will have high-resolution images taken of their lesion using the handheld LC-OCT Imaging device. The study aims to measure the number of cases with evaluable images over 1.5 years.","Not stated in the trial record.",[30],"v2"]