[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429901":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":40,"locations":49,"responsibleParty":160,"collaborators":27,"id":162,"slug":163,"hasResults":164,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":27,"eligibilityCriteria":168,"healthyVolunteers":164,"sex":169,"minAge":27,"maxAge":27,"enrollmentInfo":170,"targetDuration":27,"studyType":173,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Memorial Sloan Kettering Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A","ACTIVE_COMPARATOR","Randomized to standard technique and assessment of anastomosis without the use of NIR angiography",[13],"Diagnostic Test: Endoscopy",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B","EXPERIMENTAL","Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography",[19,20,13],"Diagnostic Test: Intravenous Indocyanine Green\u002FICG injection","Diagnostic Test: PINPOINT endoscopic fluorescence imaging system",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","Intravenous Indocyanine Green\u002FICG injection","Intravenous Indocyanine Green\u002FICG injection will be administered for visualization",[15],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"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.",[15],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Endoscopy","Standard technique and assessment of anastomosis without the use of NIR angiography",[9,15],[37],{"name":38,"affiliation":5,"role":39},"Mario Leitao, MD","PRINCIPAL_INVESTIGATOR",[41,45],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":44},"CONTACT","212-639-3987","leitaom@mskcc.org",{"name":46,"role":42,"phone":47,"phoneExt":27,"email":48},"Dennis Chi, MD","212-639-5016","chid@mskcc.org",[50,66,77,88,100,111,121,132,146],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","RECRUITING","Basking Ridge","New Jersey","07920","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-74.54932,40.70621,{"lat":62,"lon":61},[65],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":67,"status":52,"city":68,"state":54,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",{"type":59,"coordinates":71},[72,73],-74.11709,40.39428,{"lat":73,"lon":72},[76],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":78,"status":52,"city":79,"state":54,"zip":80,"country":56,"countryCode":57,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",{"type":59,"coordinates":82},[83,84],-74.02292,41.04676,{"lat":84,"lon":83},[87],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":89,"status":52,"city":90,"state":91,"zip":92,"country":56,"countryCode":57,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)","Commack","New York","11725",{"type":59,"coordinates":94},[95,96],-73.29289,40.84288,{"lat":96,"lon":95},[99],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":101,"status":52,"city":102,"state":91,"zip":103,"country":56,"countryCode":57,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",{"type":59,"coordinates":105},[106,107],-73.71263,40.96899,{"lat":107,"lon":106},[110],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":112,"status":52,"city":91,"state":91,"zip":113,"country":56,"countryCode":57,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","10065",{"type":59,"coordinates":115},[116,117],-74.00597,40.71427,{"lat":117,"lon":116},[120],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":122,"status":52,"city":123,"state":91,"zip":124,"country":56,"countryCode":57,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",{"type":59,"coordinates":126},[127,128],-73.59291,40.70038,{"lat":128,"lon":127},[131],{"name":38,"role":42,"phone":43,"phoneExt":27,"email":27},{"facility":133,"status":52,"city":134,"state":135,"zip":136,"country":56,"countryCode":57,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Jefferson Abington Hospital","Willow Grove","Pennsylvania","19090",{"type":59,"coordinates":138},[139,140],-75.11573,40.144,{"lat":140,"lon":139},[143],{"name":144,"role":42,"phone":145,"phoneExt":27,"email":27},"Leah Moukarzel, MD","215-481-4000",{"facility":147,"status":52,"city":148,"state":149,"zip":150,"country":56,"countryCode":57,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Houston Methodist Cancer Center (Data Collection Only)","Houston","Texas","77030",{"type":59,"coordinates":152},[153,154],-95.36327,29.76328,{"lat":154,"lon":153},[157],{"name":158,"role":42,"phone":159,"phoneExt":27,"email":27},"Tarrik Zaid, MD","281-275-0880",{"type":161,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100429901","phase-3-a-study-of-intra-operative-imaging-in-women-with-ovarian-cancer-100429901",false,"NCT04878094","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","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","FEMALE",{"count":171,"type":172},310,"ESTIMATED","INTERVENTIONAL",[175],"PHASE3","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.",[178,179],"Ovarian Cancer","Ovarian Carcinoma",[181,182,183,184,185,5],"Ovarian cancer","PINPOINT","rectosigmoid resection","anastomosis","21-202","2026-05-19",{"date":188,"type":189},"2026-05-20","ACTUAL",{"date":191,"type":189},"2021-05-03",{"date":193,"type":172},"2027-05-03",{"name":5,"class":6},9]