Phase 2 Study of NX9 for Delineation of Bowel Anatomy

GI Disorders Clinical Trial

Official title: APhase 2 Open Label, Study to Evaluate Safety, Pharmacokinetics & Efficacy of Oral Contrast Agent, NX9 for Delineation of Bowel Anatomy at CT Imaging With/Without IV Contrast in Subjects With Cancer or GI Disease Typically Evaluated With CT

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases
• GI Carcinoma
• GI Disorders

• NCT number: NCT04789200
• Study type: Interventional
• Source: Nextrast, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2020
• Completion date: December 1, 2021