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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ioforminol 160 mgI/mL; Drug: Ioforminol 200 mgI/mL; Drug: Iopamidol 300 mgI/mL

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1 - Ioforminol 160mgI/mL; Single administration of Ioforminol 160mgI/mL given to the subject.	Drug: Ioforminol 160 mgI/mL; Given as s single administration to the subject; Other Names: Ioforminol
EXPERIMENTAL: Arm 2 - Ioforminol 200mgI/mL; Given as a single administration to the subject	Drug: Ioforminol 200 mgI/mL; Given as a single administration to the subject; Other Names: Ioforminol
ACTIVE_COMPARATOR: Arm 3 - Iopamidol 300mgI/mL; Given as a single administration to the subject	Drug: Iopamidol 300 mgI/mL; Given as a single administration to the subject; Other Names: Isovue; Isovue 300; Iopamidol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	Within 5 minutes after administration for either Ioforminol or Iopamidol.
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).	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.	Within 5 minutes after administration for either Ioforminol or Iopamidol.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Quintiles, Inc.; Physician Reference Laboratory

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: August 9, 2012
• First Submitted That Met QC Criteria: August 24, 2012
• First Posted (ESTIMATE): August 27, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Computed Tomography; Use in Abdominal; Contrast Enhanced; Optimize concentration; dosage of Ioforminol Injection
• Other Study ID Numbers: GE-145-004