[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02507141":3,"trial-entities:NCT02507141":116,"trial-summary:NCT02507141":120},{"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":14,"conditions":16,"keywords":19,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":39,"maximum_age":14,"healthy_volunteers":40,"eligibility_criteria":41,"std_ages":50,"locations":53,"central_contacts":107,"overall_officials":110,"references":112,"see_also_links":113},"NCT02507141","15-128","Reflectance Confocal Microscopy of Oral Cancers in Vivo: a Preliminary Trial Comparing Intra-oral Imaging With Pathology","RECRUITING","2027-07","2026-08","2026-08-04","2015-07-21","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to get images (pictures) of oral lesions, which occur inside the mouth, before the patient's surgery using a special camera. These pictures will be used in our research to evaluate a new technology that uses a laser and takes pictures of the microscopic structure of tissue. The technology is called \"reflectance confocal microscopy.\" We would like to compare what the camera sees to biopsies (pathology) of the same area. We will evaluate the pictures obtained from the patient to determine whether this technology may be useful in the future. We hope this technology can be used as a tool for early diagnosis of oral cancers and for guiding surgery.",[17,18],"Head and Neck Cancer","Squamous Cell Carcinoma (SCC) of the Oral Cavity",[20,5],"Reflectance Confocal Microscopy","OBSERVATIONAL",[],{"count":24,"type":25},140,"ESTIMATED",[27],{"type":28,"name":20,"description":29,"armGroupLabels":30},"DEVICE","Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.",[31],"SCC of the oral cavity scheduled for surgery",[33],{"measure":34,"description":35,"timeFrame":36},"Reflectance Confocal Microscopy (RCM) images","Each set of images and the corresponding pathology will be evaluated by the study pathologist for the presence or absence of oral SCC. All images will be evaluated as a group. First, the pathologist will review the RCM images for each imaging site and will determine the presence\u002Fabsence of tumor. Next, the pathologist will review the corresponding histopathologic material for the presence\u002Fabsence of tumor. If there is discordance in the evaluations, the pathologist will re-evaluate the RCM images with the corresponding pathology, in a side-by-side manner, to highlight any features that may assist in the RCM evaluation.","1 year",[],"ALL","18 Years",false,{"inclusion":42,"exclusion":46,"raw_text":49},[43,44,45],"Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.","Ability to sign informed consent.","Age ≥ 18 years.",[47,48],"Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).","Inability to give informed consent.","Inclusion Criteria:\n\n* Patients with biopsy-proven oral SCC who are scheduled to undergo surgery in the MSK Head and Neck Service.\n* Ability to sign informed consent.\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.).\n* Inability to give informed consent.",[51,52],"ADULT","OLDER_ADULT",[54,67,76,86,98],{"facility":55,"status":7,"city":56,"state":57,"country":58,"contacts":59,"geoPoint":64},"Memorial Sloan Kettering Basking Ridge (consent only)","Basking Ridge","New Jersey","United States",[60],{"name":61,"role":62,"phone":63},"Snehal Patel, MD","CONTACT","212-639-3412",{"lat":65,"lon":66},40.70621,-74.54932,{"facility":68,"status":7,"city":69,"state":57,"zip":70,"country":58,"contacts":71,"geoPoint":73},"Memorial Sloan Kettering Monmouth (consent only)","Middletown","07748",[72],{"name":61,"role":62,"phone":63},{"lat":74,"lon":75},40.39428,-74.11709,{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":58,"contacts":81,"geoPoint":83},"Memorial Sloan Kettering West Harrison (consent only)","Harrison","New York","10604",[82],{"name":61,"role":62,"phone":63},{"lat":84,"lon":85},40.96899,-73.71263,{"facility":12,"status":7,"city":79,"state":79,"zip":87,"country":58,"contacts":88,"geoPoint":95},"10065",[89,90,93],{"name":61,"role":62,"phone":63},{"name":91,"role":62,"phone":92},"Milind Rajadhyaksha, PhD","646-888-6243",{"name":61,"role":94},"PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},40.71427,-74.00597,{"facility":99,"status":7,"city":100,"state":79,"zip":101,"country":58,"contacts":102,"geoPoint":104},"Memorial Sloan Kettering Nassau (consent only)","Uniondale","11553",[103],{"name":61,"role":62,"phone":63},{"lat":105,"lon":106},40.70038,-73.59291,[108,109],{"name":61,"role":62,"phone":63},{"name":91,"role":62,"phone":92},[111],{"name":61,"affiliation":12,"role":94},[],[114],{"label":12,"url":115},"https:\u002F\u002Fwww.mskcc.org\u002F",{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Oral Cavity Squamous Cell Carcinoma",[],{"nct_id":4,"found":121,"summary":122,"prompt_version":132},true,{"design":123,"status":124,"heading":125,"summary":126,"follow_up":127,"word_count":128,"commitments":129,"compensation":130,"drugs_mentioned":131},"This is an observational study planning to include up to 140 participants. Researchers will collect information and images without testing a new treatment.","completed","Reflectance Confocal Microscopy for Oral Cancers","This study is looking at a new way to take pictures of oral lesions (sores or abnormal areas in the mouth) using a special camera called Reflectance Confocal Microscopy (RCM). This camera uses a laser to take detailed pictures of tissue at a microscopic level. The goal is to see if these pictures can help doctors diagnose oral cancers earlier and guide surgery. If you have oral squamous cell carcinoma (a type of head and neck cancer) that has been confirmed by a biopsy and you are scheduled for surgery, you might be able to join. The study will compare the RCM images with your biopsy results to see how well the technology works. This is an observational study, meaning researchers are watching and collecting information, not testing a new treatment. The current status of the study is unclear.","The RCM images will be measured at 1 year, suggesting a follow-up period.",139,"If you join, Reflectance Confocal Microscopy imaging will be done during your surgery, which should take no more than 15-20 minutes.","Not stated in the trial record.",[20],"v2"]