Back to resultsPhase 2 Study of NX9 for Delineation of Bowel Anatomy
Primary Purpose
GI Carcinoma, GI Disorders
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NX9 Oral Contrast Agent
Sponsored by
About this trial
This is an interventional diagnostic trial for GI Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures
- Subject is between the ages of 18 to 85 years old, inclusive
- Has had CT of the abdomen and pelvis with IV contrast within 6 months
- 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).
- Is willing and able to comply with protocol-specified CT scanning and visits to the clinic
- Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds
- Is able to drink 1.2 liters of fluid within 45 minutes
- Has good venous access as determined by the Investigator at screening
- Is an outpatient who is able and willing to come to the clinic for study visits
Exclusion Criteria:
- 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
- Has a history of or is currently suffering from a known gastrointestinal motility disorder, e.g. severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.
- Has symptoms of a possible current bowel obstruction
- Has a moderate to high risk of current bowel perforation
- 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.
- Has a contraindication (i.e. allergy) to IV or Oral CT contrast
- If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening
- Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
Sites / Locations
- Mayo Clinic
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NX9 oral contrast agent
Arm Description
Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid.
Outcomes
Primary Outcome Measures
Marking and distension of the bowel lumen at CT of the abdomen
Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Readers will assess the Stomach, duodenum, jejunum, ileum, terminal ileum, proximal colon, and distal colon to record the bowel distension as the diameter of the bowel measured as mm distance from inner wall to inner wall, and the marking of bowel as the fraction of bowel length marked by NX9 contrast agent rated on a 5 point scale from 0=none, 1=0 to <25%, 2=25 to <50%, 3=50 to <75%, and 4=75 to 100% the length of the bowel.
Secondary Outcome Measures
Safety: Incidence of Treatment-Emergent Adverse Events as assessed by physical exam findings and symptoms reported verbatim by subjects.
Changes from pre-dose physical exam will be assessed by the PI and recorded as an adverse event, either related or not related to study drug. Additionally, subjects will be queried as to how they are feeling immediately following administration of study drug through 4 hours post-administration, on their Day 3 visit and during the Day 14 phone call. All symptoms will be evaluated by the PI and recorded as adverse events as appropriate. For example, if there are symptoms that are not in keeping with their pre-dose medical history.
Safety: Changes in Hematology, Chemistry and Urinalysis parameters - Screening to Post-NX9 dosing
An abnormal laboratory result or a change from baseline will be considered an AE if it induces clinical signs or symptoms, if the abnormality is of a degree that requires active management (e.g. discontinuation of the study drug, dose modification) or when the event is requiring treatment or other therapeutic intervention (e.g. iron supplements, blood transfusion, etc.). The following parameters will be evaluated: Hematology (Hgb, RBC, WBC, Platelets, HCT), Chemistry (BUN, Creatinine, ALT, AST, GGT, LDH, AlkPhos, Total Bilirubin, Glucose, Albumin, Total Protein, Sodium, Calcium, Potassium, Phosphate, Chloride, Bicarbonate, Urate, Total Cholesterol), Urinalysis (pH, Specific gravity, Glucose, Protein, Ketones, Bilirubin, Blood, Nitrites, Leukocytes, Urobilinogen). Analysis will look for trends in clinical laboratory abnormalities.
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.
Standard 12-lead ECGs will be taken on the Day of dosing approximately 1 hour prior to dosing and at 4 hours post-dose and on the Day 3 follow up visit. The following parameters will be recorded (Ventricular rate in bpm, PR interval, RR interval, QRS interval, QT interval, QTcF and overall reading. Any clinically significant findings and changes will be investigated by the PI and reported as AEs if appropriate.
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.
Standard 12-lead ECGs will be taken on the Day of dosing approximately 1 hour prior to dosing and at 4 hours post-dose and on the Day 3 follow up visit. The following parameters will be recorded (Ventricular rate in bpm, PR interval, RR interval, QRS interval, QT interval, QTcF and overall reading. Any clinically significant findings and changes will be investigated by the PI and reported as AEs if appropriate.
PK: Maximum serum concentration of NX9 following dosing will be assessed in the PK subgroup.
Serum samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.
PK: Maximum urine concentration of NX9 following dosing will be assessed in the PK subgroup.
Urine samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.
Delineation of bowel wall enhancement related to concurrent intravenous contrast at CT of the abdomen and pelvis
Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Scored on 4-point scale where 0=Cannot determine presence or absence of IV contrast enhancement of bowel wall for any of the oral contrast-filled bowel,1=IV contrast enhancement of bowel wall is clearly assessed for less than half of the oral contrast-filled bowel, 2=IV contrast enhancement of bowel wall is clearly assessed for most of the oral contrast-filled bowel, and 3=IV contrast enhancement of bowel wall is clearly assessed for all of the oral contrast-filled bowel
Full Information
NCT ID
NCT04789200
First Posted
March 2, 2021
Last Updated
January 13, 2022
Sponsor
Nextrast, Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT04789200
Brief Title
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nextrast, Inc.
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GI Carcinoma, GI Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NX9 oral contrast agent
Arm Type
Experimental
Arm Description
Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid.
Intervention Type
Drug
Intervention Name(s)
NX9 Oral Contrast Agent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Marking and distension of the bowel lumen at CT of the abdomen
Description
Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Readers will assess the Stomach, duodenum, jejunum, ileum, terminal ileum, proximal colon, and distal colon to record the bowel distension as the diameter of the bowel measured as mm distance from inner wall to inner wall, and the marking of bowel as the fraction of bowel length marked by NX9 contrast agent rated on a 5 point scale from 0=none, 1=0 to <25%, 2=25 to <50%, 3=50 to <75%, and 4=75 to 100% the length of the bowel.
Time Frame
approximately 30 minutes
Secondary Outcome Measure Information:
Title
Safety: Incidence of Treatment-Emergent Adverse Events as assessed by physical exam findings and symptoms reported verbatim by subjects.
Description
Changes from pre-dose physical exam will be assessed by the PI and recorded as an adverse event, either related or not related to study drug. Additionally, subjects will be queried as to how they are feeling immediately following administration of study drug through 4 hours post-administration, on their Day 3 visit and during the Day 14 phone call. All symptoms will be evaluated by the PI and recorded as adverse events as appropriate. For example, if there are symptoms that are not in keeping with their pre-dose medical history.
Time Frame
Up to 14 days
Title
Safety: Changes in Hematology, Chemistry and Urinalysis parameters - Screening to Post-NX9 dosing
Description
An abnormal laboratory result or a change from baseline will be considered an AE if it induces clinical signs or symptoms, if the abnormality is of a degree that requires active management (e.g. discontinuation of the study drug, dose modification) or when the event is requiring treatment or other therapeutic intervention (e.g. iron supplements, blood transfusion, etc.). The following parameters will be evaluated: Hematology (Hgb, RBC, WBC, Platelets, HCT), Chemistry (BUN, Creatinine, ALT, AST, GGT, LDH, AlkPhos, Total Bilirubin, Glucose, Albumin, Total Protein, Sodium, Calcium, Potassium, Phosphate, Chloride, Bicarbonate, Urate, Total Cholesterol), Urinalysis (pH, Specific gravity, Glucose, Protein, Ketones, Bilirubin, Blood, Nitrites, Leukocytes, Urobilinogen). Analysis will look for trends in clinical laboratory abnormalities.
Time Frame
Up to 14 days
Title
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.
Description
Standard 12-lead ECGs will be taken on the Day of dosing approximately 1 hour prior to dosing and at 4 hours post-dose and on the Day 3 follow up visit. The following parameters will be recorded (Ventricular rate in bpm, PR interval, RR interval, QRS interval, QT interval, QTcF and overall reading. Any clinically significant findings and changes will be investigated by the PI and reported as AEs if appropriate.
Time Frame
Up to 14 days
Title
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.
Description
Standard 12-lead ECGs will be taken on the Day of dosing approximately 1 hour prior to dosing and at 4 hours post-dose and on the Day 3 follow up visit. The following parameters will be recorded (Ventricular rate in bpm, PR interval, RR interval, QRS interval, QT interval, QTcF and overall reading. Any clinically significant findings and changes will be investigated by the PI and reported as AEs if appropriate.
Time Frame
Up to 14 days
Title
PK: Maximum serum concentration of NX9 following dosing will be assessed in the PK subgroup.
Description
Serum samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.
Time Frame
Up to 2 days
Title
PK: Maximum urine concentration of NX9 following dosing will be assessed in the PK subgroup.
Description
Urine samples will be taken at about 2 hours pre-dose, 60 minutes post dose, 4 hours post-dose and 72 hours post dose and evaluated for Cmax.
Time Frame
Up to 2 days
Title
Delineation of bowel wall enhancement related to concurrent intravenous contrast at CT of the abdomen and pelvis
Description
Evaluated by CT imaging of the abdomen and pelvis taken in the following order: VLDCT without contrast, VLDCT with NX9 oral contrast; Scored on 4-point scale where 0=Cannot determine presence or absence of IV contrast enhancement of bowel wall for any of the oral contrast-filled bowel,1=IV contrast enhancement of bowel wall is clearly assessed for less than half of the oral contrast-filled bowel, 2=IV contrast enhancement of bowel wall is clearly assessed for most of the oral contrast-filled bowel, and 3=IV contrast enhancement of bowel wall is clearly assessed for all of the oral contrast-filled bowel
Time Frame
approximately 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Understands the requirements of the study and provides written informed consent prior to undergoing any study-related procedures
Subject is between the ages of 18 to 85 years old, inclusive
Has had CT of the abdomen and pelvis with IV contrast within 6 months
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).
Is willing and able to comply with protocol-specified CT scanning and visits to the clinic
Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds
Is able to drink 1.2 liters of fluid within 45 minutes
Has good venous access as determined by the Investigator at screening
Is an outpatient who is able and willing to come to the clinic for study visits
Exclusion Criteria:
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
Has a history of or is currently suffering from a known gastrointestinal motility disorder, e.g. severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.
Has symptoms of a possible current bowel obstruction
Has a moderate to high risk of current bowel perforation
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.
Has a contraindication (i.e. allergy) to IV or Oral CT contrast
If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening
Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Davis, MD
Organizational Affiliation
Nextrast, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD that supports publications and presentations.
IPD Sharing Time Frame
During the review cycle for publications and presentations or post-publication when requested and approved, dependent on use of such information
IPD Sharing Access Criteria
Written requests to be submitted to the Nextrast with plan for use of such information.
Learn more about this trial
Phase 2 Study of NX9 for Delineation of Bowel Anatomy
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