A Study to Evaluate the Safety and Effectiveness of NX9 for CT Imaging in Patients with Cancer or GI Disease

Overview

About this study

The purpose of this study is to collect safety, effectiveness and pharmacokinetics (in a subgroup of subjects) data on the use of NX9 as an oral CT contrast agent.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 and agrees to submit the results and images of a CT that shows some disease of the bowel or disease adjacent to bowel (e.g., peritoneal disease, carcinomatosis, omental caking or bowel inflammation), such that there is a reasonably high chance that the study CT scan could also show disease and which was:
    • conducted within 6 months prior to study entry;
    • conducted with IV and either positive or neutral oral contrast.
  • 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 ± 2 days 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Bruining, M.D.

Open for enrollment

Contact information:

Julie Faust R.N.

(507)266-3242

Faust.Julie@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20485420

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