Phase 2 Study of NX9 for Delineation of Bowel Anatomy

NCT ID: NCT04789200

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

NX9 oral contrast agent

Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid.

Group Type: EXPERIMENTAL

NX9 Oral Contrast Agent

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Nextrast, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Davis, MD

Role: STUDY_DIRECTOR

Nextrast, Inc.

Locations

Mayo Clinic

Rochester, Minnesota, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

5R44DK103495

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NX9-PH2-01

Identifier Type: -

Identifier Source: org_study_id