Phase 2 Study of NX9 for Delineation of Bowel Anatomy
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Nextrast, Inc.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)