Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Ioforminol 160 mgI/mL; Drug: Iopamidol 300 mgI/mL; Drug: Ioforminol 200 mgI/mL

• Registration Number: NCT01672996
• Lead Sponsor: GE Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-24
• Study First Posted: 2012-08-27
• Results First Submitted: 2014-01-17
• Results First Submitted QC: 2014-01-17
• Results First Posted: 2014-03-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - Ioforminol 160mgI/mL	Ioforminol 160 mgI/mL	Single administration of Ioforminol 160mgI/mL given to the subject.
Arm 3 - Iopamidol 300mgI/mL	Iopamidol 300 mgI/mL	Given as a single administration to the subject
Arm 2 - Ioforminol 200mgI/mL	Ioforminol 200 mgI/mL	Given as a single administration to the subject

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).	Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.	Recording the occurrence of treatment emergent adverse events (TEAE).

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States