Clinical trial NCT04789200: Phase 2 Study of NX9 for Delineation of Bowel Anatomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GI Carcinoma
GI Disorders
Lead sponsor: Nextrast, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-09
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Marking and distension of the bowel lumen at CT of the abdomen
timeFrame: approximately 30 minutes
Secondary outcomes:
measure: Safety: Incidence of Treatment-Emergent Adverse Events as assessed by physical exam findings and symptoms reported verbatim by subjects.
timeFrame: Up to 14 days
measure: Safety: Changes in Hematology, Chemistry and Urinalysis parameters - Screening to Post-NX9 dosing
timeFrame: Up to 14 days
measure: Safety: ECGs will be used to assess clinically significant changes that may be indicative of a treatment-emergent AE. Analysis will look for overall trends in ECG changes post-dosing.
timeFrame: Up to 14 days
measure: Safety: Changes in vital signs from Screening to Post-study drug administration will be assessed for clinical significance and possibility that they are indicative of an AE. Analysis will look for overall trends in vital sign changes post-dosing.
timeFrame: Up to 14 days
measure: PK: Maximum serum concentration of NX9 following dosing will be assessed in the PK subgroup.
timeFrame: Up to 2 days
measure: PK: Maximum urine concentration of NX9 following dosing will be assessed in the PK subgroup.
timeFrame: Up to 2 days
measure: Delineation of bowel wall enhancement related to concurrent intravenous contrast at CT of the abdomen and pelvis
timeFrame: approximately 30 minutes
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Nextrast, Inc.
name: Michael Davis, MD
role: STUDY_DIRECTOR
References: