GI CarcinomaPhase 2NCT04789200
Phase 2 Study of NX9 for Delineation of Bowel Anatomy
A Phase 2 study testing NX9 Oral Contrast Agent in people with GI Carcinoma and GI Disorders, run by Nextrast, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- GI Carcinoma, GI Disorders
- What is being tested?
- NX9 Oral Contrast Agent
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2020to 1 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98109
About this study
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
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
- Being tested
- NX9 Oral Contrast Agent
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NX9 Oral Contrast AgentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NX9 oral contrast agent | Experimental | Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid. Receives: Drug: NX9 Oral Contrast Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: approximately 30 minutes
Secondary outcomes (7)
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
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.
Measured: Up to 14 days
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.
Measured: Up to 2 days
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.
Measured: Up to 2 days
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
Measured: approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Aug 2020
- Primary completion1 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nextrast, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Davis, MD, Study director, Nextrast, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789200
- Sponsor's protocol ID
- NX9-PH2-01
- Other IDs
- 5R44DK103495
- Status last verified
- Jan 2022
- First submitted
- 2 Mar 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that supports publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04789200
- Acronym / sponsor ID
- NX9-PH2-01
- Conditions
- GI Carcinoma, GI Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nextrast, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NX9 oral contrast agent | Experimental | Drug: NX9 Oral Contrast AgentSubjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NX9 Oral Contrast AgentDistension 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. | Drug | NX9 oral contrast agent |
Primary outcome
Marking and distension of the bowel lumen at CT of the abdomen
Time frame: approximately 30 minutes
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.
7 secondary outcomes
Safety: Incidence of Treatment-Emergent Adverse Events as assessed by physical exam findings and symptoms reported verbatim by subjects.
Time frame: Up to 14 days
Safety: Changes in Hematology, Chemistry and Urinalysis parameters - Screening to Post-NX9 dosing
Time frame: Up to 14 days
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.
Time frame: Up to 14 days
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.
Time frame: Up to 14 days
PK: Maximum serum concentration of NX9 following dosing will be assessed in the PK subgroup.
Time frame: Up to 2 days
PK: Maximum urine concentration of NX9 following dosing will be assessed in the PK subgroup.
Time frame: Up to 2 days
Delineation of bowel wall enhancement related to concurrent intravenous contrast at CT of the abdomen and pelvis
Time frame: approximately 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: Yes. IPD that supports publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Davis, MD study director
Nextrast, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NX9 Oral Contrast Agent in people with GI Carcinoma and GI Disorders, run by Nextrast, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marking and distension of the bowel lumen at CT of the abdomen (time frame: approximately 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.