{"preliminary_commentary":{"by_channel":{"x_thread":5,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":"breast cancer","name":"INSITE","nct_id":"NCT03686215","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=insite-nct03686215. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"INSITE","arms":[{"description":"The LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015.","label":"Device Intervention: LUM Imaging System used during surgery","type":"EXPERIMENTAL"},{"description":"The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.","label":"Standard of Care Arm","type":"NO_INTERVENTION"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2022-05-04","type":"ACTUAL"},"conditions":["Breast Cancer"],"enrollment":{"count":406,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Study Device Arm","otherNames":["LUM Imaging System"],"type":"COMBINATION_PRODUCT"}],"last_update":"2026-10-26","lead_sponsor":"Lumicell, Inc.","official_title":"Pivotal Study of the LUM Imaging System for Assisting Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Patients With Breast Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2021-12-09","type":"ACTUAL"},"primary_outcomes":[{"measure":"Percentage of Patients Who Had Residual Cancer Found in at Least One LUM Imaging System Guided Shave Among All Patients.","timeFrame":"Day 1, during surgery"},{"measure":"Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity","timeFrame":"Day 1, during surgery"},{"measure":"Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity","timeFrame":"Day 1, during surgery"}],"references":[{"citation":"Smith BL, Hunt KK, Carr D, Blumencranz PW, Hwang ES, Gadd MA, Stone K, Dyess DL, Dodge D, Valente S, Dekhne N, Clark P, Lee MC, Samiian L, Lesnikoski BA, Clark L, Smith KP, Chang M, Harris DK, Schlossberg B, Ferrer J, Wapnir IL. Intraoperative Fluorescence Guidance for Breast Cancer Lumpectomy Surgery. NEJM Evid. 2023 Jul;2(7):EVIDoa2200333. doi: 10.1056/EVIDoa2200333. Epub 2023 Apr 27.","pmid":"38320161","type":"RESULT"}],"start_date":{"date":"2019-11-04","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Investigation of Novel Surgical Imaging for Tumor Excision","url":"https://clinicaltrials.gov/study/NCT03686215"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/insite-nct03686215"}