Phase 2 Study of NX9 for Delineation of Bowel Anatomy

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nextrast, Inc.
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Criteria

Inclusion Criteria:

1. Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures

2. Subject is between the ages of 18 to 85 years old, inclusive

3. Has had CT of the abdomen and pelvis with IV contrast within 6 months

4. Has a concern for disease involvement of the bowel or structure adjacent to bowel (e.g. peritoneal disease, carcinomatosis, omental cake, bowel inflammation, lymphadenopathy, or fluid collection).

5. Is willing and able to comply with protocol-specified CT scanning and visits to the clinic

6. Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds

7. Is able to drink 1.2 liters of fluid within 45 minutes

8. Has good venous access as determined by the Investigator at screening

9. Is an outpatient who is able and willing to come to the clinic for study visits

Exclusion Criteria:

1. Has any co-morbidity that the Investigator judges will interfere with their ability to complete the study or undergo a quality CT scan, e.g. high risk of aspiration

2. Has a history of or is currently suffering from a known gastrointestinal motility disorder, e.g. severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.

3. Has symptoms of a possible current bowel obstruction

4. Has a moderate to high risk of current bowel perforation

5. Subject should not schedule a GI diagnostic surgery or hospitalization for any procedure until after the study follow-up on Day 14 day. However, if at the time of study entry, the subject has pre-planned a surgery or hospitalization, it may be allowed at the discretion of the PI provided it does not take place until after the subject completes the Day 3 visit.

6. Has a contraindication (i.e. allergy) to IV or Oral CT contrast

7. If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening

8. Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.