[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04878094":3,"trial-entities:NCT04878094":157,"trial-summary:NCT04878094":163},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":48,"secondary_outcomes":53,"sex":54,"minimum_age":15,"maximum_age":15,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":72,"locations":76,"central_contacts":144,"overall_officials":145,"references":149,"see_also_links":154},"NCT04878094","21-202","A Study of Intra-operative Imaging in Women With Ovarian Cancer","ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer","ACTIVE_NOT_RECRUITING","2027-05-03","2026-08","2026-08-27","2021-05-03","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.",[18,19],"Ovarian Cancer","Ovarian Carcinoma",[21,22,23,24,5,13],"Ovarian cancer","PINPOINT","rectosigmoid resection","anastomosis","INTERVENTIONAL","DIAGNOSTIC",[28],"PHASE3",{"count":30,"type":31},155,"ACTUAL",[33,39,43],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DIAGNOSTIC_TEST","Intravenous Indocyanine Green\u002FICG injection","Intravenous Indocyanine Green\u002FICG injection will be administered for visualization",[38],"Arm B",{"type":34,"name":40,"description":41,"armGroupLabels":42},"PINPOINT endoscopic fluorescence imaging system","After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.",[38],{"type":34,"name":44,"description":45,"armGroupLabels":46},"Endoscopy","Standard technique and assessment of anastomosis without the use of NIR angiography",[47,38],"Arm A",[49],{"measure":50,"description":51,"timeFrame":52},"Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone","To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone.","45 days post procedure",[],"FEMALE",false,{"inclusion":57,"exclusion":65,"raw_text":71},[58,59,60,61,62,63,64],"18 years or older","Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer","Scheduled to undergo debulking or cytoreductive surgery","Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure","Enrolled and consented before the operation","Completed rectosigmoid resection","Surgeon plans to perform colorectal anastomosis",[66,67,68,69,70],"Documented history of allergic reaction to ICG","Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection","Did not undergo rectosigmoid resection intraoperatively","Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy","Patient requires permanent colostomy","Participant Inclusion Criteria\n\nPart 1 (pre-operative):\n\n* 18 years or older\n* Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer\n* Scheduled to undergo debulking or cytoreductive surgery\n* Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure\n* Enrolled and consented before the operation\n\nPart 2 (intra-operative):\n\n* Completed rectosigmoid resection\n* Surgeon plans to perform colorectal anastomosis\n\nParticipant Exclusion Criteria\n\nPart 1 (pre-operative):\n\n* Documented history of allergic reaction to ICG\n* Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection\n\nPart 2 (intra-operative):\n\n* Did not undergo rectosigmoid resection intraoperatively\n* Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy\n* Patient requires permanent colostomy",[73,74,75],"CHILD","ADULT","OLDER_ADULT",[77,86,93,100,108,115,121,128,136],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",{"lat":84,"lon":85},40.70621,-74.54932,{"facility":87,"city":88,"state":80,"zip":89,"country":82,"geoPoint":90},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"lat":91,"lon":92},40.39428,-74.11709,{"facility":94,"city":95,"state":80,"zip":96,"country":82,"geoPoint":97},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"lat":98,"lon":99},41.04676,-74.02292,{"facility":101,"city":102,"state":103,"zip":104,"country":82,"geoPoint":105},"Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"lat":106,"lon":107},40.84288,-73.29289,{"facility":109,"city":110,"state":103,"zip":111,"country":82,"geoPoint":112},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"lat":113,"lon":114},40.96899,-73.71263,{"facility":116,"city":103,"state":103,"zip":117,"country":82,"geoPoint":118},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"lat":119,"lon":120},40.71427,-74.00597,{"facility":122,"city":123,"state":103,"zip":124,"country":82,"geoPoint":125},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"lat":126,"lon":127},40.70038,-73.59291,{"facility":129,"city":130,"state":131,"zip":132,"country":82,"geoPoint":133},"Jefferson Abington Hospital","Willow Grove","Pennsylvania","19090",{"lat":134,"lon":135},40.144,-75.11573,{"facility":137,"city":138,"state":139,"zip":140,"country":82,"geoPoint":141},"Houston Methodist Cancer Center (Data Collection Only)","Houston","Texas","77030",{"lat":142,"lon":143},29.76328,-95.36327,[],[146],{"name":147,"affiliation":13,"role":148},"Mario Leitao, MD","PRINCIPAL_INVESTIGATOR",[150],{"pmid":151,"type":152,"citation":153},"38514101","DERIVED","Leitao MM Jr, Iasonos A, Tomberlin M, Moukarzel LA, Price H, Bennetti G, Ramesh B, Chi DS, Long Roche K, Sonoda Y, Al-Niami A, Mueller JJ, Gardner GJ, Broach V, Jewell EL, Kim S, Feinberg J, Abu-Rustum NR, Zivanovic O. ARIA II: a randomized controlled trial of near-infrared Angiography during RectosIgmoid resection and Anastomosis in women with ovarian cancer. Int J Gynecol Cancer. 2024 Jul 1;34(7):1098-1101. doi: 10.1136\u002Fijgc-2024-005395.",[155],{"label":13,"url":156},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":158,"biomarkers":162},[159,160,161],"Fallopian Tube Carcinoma","Malignant Ovarian Neoplasm","Primary Peritoneal Cancer",[],{"nct_id":4,"found":164,"summary":165,"prompt_version":174},true,{"design":166,"status":167,"heading":6,"summary":168,"follow_up":169,"word_count":170,"commitments":171,"compensation":172,"drugs_mentioned":173},"This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 310 women.","completed","This study is investigating whether using a special imaging system called PINPOINT during surgery for ovarian cancer can help reduce complications, specifically anastomotic leaks (where surgical connections don't heal properly). The PINPOINT system uses a fluorescent (glowing) dye called Intravenous Indocyanine Green\u002FICG and a special camera to show blood flow in real-time. This allows surgeons to identify and fix any issues during the operation. The study aims to see if this method is better than standard surgical assessment alone. You may be able to join if you are a woman aged 18 or older with ovarian, fallopian tube, or primary peritoneal cancer, are scheduled for debulking surgery, and are expected to need a rectosigmoid resection. The study is currently unclear on its recruitment status and plans to enroll 310 participants. Success will be measured by a reduction in the risk of anastomotic leaks 30 days after surgery.","The primary outcome is measured 45 days after the procedure to assess the risk of anastomotic leak.",147,"You would undergo an Intravenous Indocyanine Green\u002FICG injection and the PINPOINT endoscopic fluorescence imaging system would be used during your surgery. Standard endoscopy would also be performed.","Not stated in the trial record.",[],"v2"]