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

NCT01672996 | Completed Phase 1 Results

• 1 other identifier: GE-145-004
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Use in Abdominal; Contrast Enhanced; Computed Tomography; Optimize concentration; dosage of Ioforminol Injection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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.

Study Arms (3)

Arm 1 - Ioforminol 160mgI/mL

EXPERIMENTAL

Single administration of Ioforminol 160mgI/mL given to the subject.

Drug: Ioforminol 160 mgI/mL

Arm 2 - Ioforminol 200mgI/mL

EXPERIMENTAL

Given as a single administration to the subject

Drug: Ioforminol 200 mgI/mL

Arm 3 - Iopamidol 300mgI/mL

ACTIVE COMPARATOR

Given as a single administration to the subject

Drug: Iopamidol 300 mgI/mL

Interventions

Ioforminol 160 mgI/mL DRUG

Given as s single administration to the subject

Also known as: Ioforminol

Arm 1 - Ioforminol 160mgI/mL

Ioforminol 200 mgI/mL DRUG

Given as a single administration to the subject

Also known as: Ioforminol

Arm 2 - Ioforminol 200mgI/mL

Iopamidol 300 mgI/mL DRUG

Given as a single administration to the subject

Also known as: Iopamidol, Isovue 300, Isovue

Arm 3 - Iopamidol 300mgI/mL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females between 18 and 50 years of age.
• The subject has a maximum abdominal circumference of 120 cm or less.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Physician Reference Laboratory: collaborator
• Quintiles, Inc.: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Interventions

Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Rubin Sheng, MD
• Organization: GE Healthcare

Rubin.Sheng@ge.com

609-514-6899

Study Officials

• Rubin Sheng, MD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 27, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 29, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-04

Locations

US (1)