{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2020"],"data_sharing_plan":["IPD Sharing (as of January 2022): Yes\nDescription: IPD that supports publications and presentations.\nTime frame: During the review cycle for publications and presentations or post-publication when requested and approved, dependent on use of such information\nAccess Criteria: Written requests to be submitted to the Nextrast with plan for use of such information.\nAdditional information available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report"],"condition":["Gastrointestinal Diseases","GI Carcinoma","Digestive System Diseases","GI Disorders"],"disease":["Gi Disorders","Gastrointestinal Diseases","Digestive System Diseases","Gi Carcinoma"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2370031"],"location":["United States"],"study_start_month":["8"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"Phase 2 Study of NX9 for Delineation of Bowel Anatomy","description":"This study will evaluate marking and distention of the bowel of the oral contrast agent, NX9, at CT of the abdomen and pelvis, VLDCT with no contrast will be followed by VLDCT with NX9 contrast followed by CT with NX9 and standard IV contrast. Eligible subjects will have cancer or other GI disorders for which CT is typically used to assess their disease. This is an open label study with efficacy evaluated in a masked fashion following completion of the entire study. Results of the NX9 scans will not be used for treatment decisions. PK will be evaluated in a subset of subjects at a single center.","dates":{"creation":"2020-08-15"},"accession":"2370031","cross_references":{"ClinicalTrials___gov":["NCT04789200"]}}