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OpenTrials
Completed

NCT Number: NCT01672996

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

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ioforminol 160 mgI/mL

Drug

Given as s single administration to the subject

Other names: Ioforminol

Ioforminol 200 mgI/mL

Drug

Given as a single administration to the subject

Other names: Ioforminol

Iopamidol 300 mgI/mL

Drug

Given as a single administration to the subject

Other names: Iopamidol, Isovue 300, Isovue

Primary outcomes

  1. 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.

    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.

  2. 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.

    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 outcomes

  1. 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.

    Recording the occurrence of treatment emergent adverse events (TEAE).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Physician Reference Laboratory
  • Quintiles, Inc.

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2012
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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