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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Marking and distension of the bowel lumen at CT of the abdomen
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
NX9 oral contrast agent
Subjects will be given a 9% w/w HBGM concentration of NX9 provided as 1.2L of liquid.
干预措施: NX9 Oral Contrast Agent (Drug)
结局指标
主要结局
Marking and distension of the bowel lumen at CT of the abdomen
时间窗: 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.
次要结局
- Safety: Changes in Hematology, Chemistry and Urinalysis parameters - Screening to Post-NX9 dosing(Up to 14 days)
- Safety: Incidence of Treatment-Emergent Adverse Events as assessed by physical exam findings and symptoms reported verbatim by subjects.(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.(Up to 14 days)
- PK: Maximum urine concentration of NX9 following dosing will be assessed in the PK subgroup.(Up to 2 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.(Up to 14 days)
- PK: Maximum serum concentration of NX9 following dosing will be assessed in the PK subgroup.(Up to 2 days)
- Delineation of bowel wall enhancement related to concurrent intravenous contrast at CT of the abdomen and pelvis(approximately 30 minutes)