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A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
Details
| Lead sponsor | GE Healthcare |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 66 |
| Start date | 2012-07 |
| Completion | 2012-08 |
Conditions
- Healthy
Interventions
- Ioforminol 160 mgI/mL
- Ioforminol 200 mgI/mL
- Iopamidol 300 mgI/mL
Primary outcomes
- Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). — Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. - Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). — Within 5 minutes after administration for either Ioforminol or Iopamidol.
Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU.
Countries
United States