[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054577":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":12,"responsibleParty":7,"collaborators":7,"id":26,"slug":27,"hasResults":28,"nctId":29,"briefTitle":30,"officialTitle":30,"acronym":7,"eligibilityCriteria":31,"healthyVolunteers":28,"sex":32,"minAge":7,"maxAge":7,"enrollmentInfo":33,"targetDuration":7,"studyType":35,"phases":36,"briefSummary":38,"conditions":39,"keywords":41,"overallStatus":47,"whyStopped":7,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":57},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","2-Fluoro-2-deoxyglucose",[13],{"facility":14,"status":7,"city":15,"state":16,"zip":17,"country":18,"countryCode":19,"cosmosGeoPoint":20,"geoPoint":25,"contacts":7},"National Cancer Institute (NCI)","Bethesda","Maryland","20892","United States","US",{"type":21,"coordinates":22},"Point",[23,24],-77.10026,38.98067,{"lat":24,"lon":23},"100054577","phase-2-phase-ii-study-of-the-role-of-anti-cea-antibody-immunoscintigraphy--positron-emission-tomography-in-the-localization-of-recurrent-colorectal-carcinoma-in-patients-with-rising-serum-cea-levels-in-the-absence-of-imageable-disease-by-conventional-modalities-100054577",false,"NCT00001568","Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities","All patients greater than 18 years old who have had a prior resection of colorectal cancer and are suspected of having recurrent disease.\n\nRising serum CEA levels greater than 6 on two successive tests.\n\nResectable residual or recurrent disease. Patients in the occult arm (Arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. In addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; CT scan of chest\u002F abdomen\u002F pelvis with contrast, MRI scan, and chest x-ray. Patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.\n\nPatients must have an ECOG performance status of 0-1.\n\nPatients must be willing to return to NIH for follow-up.\n\nPatients must be able to provide informed consent as demonstrated by the signed consent.\n\nPatients must be 2 or more months from abdominal or thoracic surgery.\n\nNo patients with medical contraindication to abdominal exploration.\n\nNo patients with recurrent disease detected by conventional imaging studies as outlined above. Metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. Patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.\n\nNo patients with previous injection of murine monoclonal antibodies: Human anti-mouse assay (HAMA) will be performed in patients with prior history of receiving murine monoclonal antibodies.\n\nNo patients that are pregnant or breast feeding.\n\nPatients who are HIV + will be excluded.","ALL",{"count":34,"type":7},200,"INTERVENTIONAL",[37],"PHASE2","Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.\n\nFor CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.\n\nPatients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.\n\nAt the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.\n\nPatients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.",[40],"Colorectal Neoplasm",[42,43,44,45,46],"Tumors","Detection","Follow-Up","Markers","Radiolabeled","COMPLETED","2008-03-03",{"date":50,"type":51},"2008-03-04","ESTIMATED",{"date":53,"type":7},"1997-02",{"date":55,"type":7},"2002-10",{"name":14,"class":6},1]