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

This study has been completed.
Sponsor:
Collaborators:
Physician Reference Laboratory
Quintiles
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01672996
First received: August 9, 2012
Last updated: May 13, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Ioforminol 160 mgI/mL
Drug: Ioforminol 200 mgI/mL
Drug: Iopamidol 300 mgI/mL
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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). [ Time Frame: Within 5 minutes after administration for either Ioforminol or Iopamidol. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Within 5 minutes after administration for either Ioforminol or Iopamidol. ] [ Designated as safety issue: No ]
    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:
  • Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). [ Time Frame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration. ] [ Designated as safety issue: Yes ]
    Recording the occurrence of treatment emergent adverse events (TEAE).


Enrollment: 66
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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:
  • Iopamidol
  • Isovue 300
  • Isovue

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672996

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Physician Reference Laboratory
Quintiles
Investigators
Study Director: Rubin Sheng, MD GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01672996     History of Changes
Other Study ID Numbers: GE-145-004
Study First Received: August 9, 2012
Results First Received: January 17, 2014
Last Updated: May 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GE Healthcare:
Use in Abdominal
Contrast Enhanced
Computed Tomography
Optimize concentration
dosage of Ioforminol Injection

Additional relevant MeSH terms:
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014