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

GE Healthcare66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Ioforminol 160 mgI/mLDRUG

Given as s single administration to the subject

Ioforminol 200 mgI/mLDRUG

Given as a single administration to the subject

Iopamidol 300 mgI/mLDRUG

Given as a single administration to the subject

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: Within 5 minutes after administration for either Ioforminol or Iopamidol.

Secondary Outcomes

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).

Time frame: Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.