Phase 2
N=66
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01672996 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: 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). — 168; 261; 345; 341 Hounsfield Units
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ioforminol 160 mgI/mL (Drug); Ioforminol 200 mgI/mL (Drug); Iopamidol 300 mgI/mL (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
168; 261; 345; 341; 357; 365 | — |
| PRIMARY 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). |
191; 230; 212; 261; 246; 240 | — |
| SECONDARY Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). |
3; 5; 13; 8; 5; 7 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Healthy males or females between 18 and 50 years of age.
- The subject has a maximum abdominal circumference of 120 cm or less.
Exclusion Criteria
- The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent or with history of multiple allergies (i.e., foods, pets, medications, etc).
- The subject has chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <60 mg/dL) as measured at the screening visit.
- The subject is pregnant or breast-feeding.
- The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
- The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
- The subject is taking metformin (e.g., Glucophage®) therapy.
Data sourced from ClinicalTrials.gov (NCT01672996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.