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Phase 2 Study of NX9 for Delineation of Bowel Anatomy

NCT04789200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-01-18

No results posted yet for this study

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.

Conditions

  • GI Carcinoma
  • GI Disorders

Interventions

DRUG

NX9 Oral Contrast Agent

Distension and marking of the bowel lumen will be compared between the 1st and 2nd scan. Ability to see IV contrast enhancement will be assessed on the 3rd scan in relationship to the 2nd scan.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Nextrast, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Davis, MD · Nextrast, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2021-11-01
Completion
2021-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789200 on ClinicalTrials.gov