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

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01672996
• Collaborator: Physician Reference Laboratory (Other), Quintiles, Inc. (Industry)
• Enrollment: 66
• Location: 1
• Arms: 3
• Duration (Months): 1
• Patients Per Site Per Month: 64.8

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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: Iopamidol Isovue 300 Isovue

Outcome Measures

Primary Outcome Measures

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). [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). [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 Outcome Measures

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.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	GE Healthcare	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• GE Healthcare
• Physician Reference Laboratory
• Quintiles, Inc.

Investigators

• Study Director: Rubin Sheng, MD, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01672996
• Other Study ID Numbers: GE-145-004
• First Posted: Aug 27, 2012
• Last Update Posted: May 29, 2014
• Last Verified: Apr 1, 2014

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

Study Results

Participant Flow

Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL	Arm 2 - Ioforminol 200mgI/mL	Arm 3 - Iopamidol 300mgI/mL
Arm/Group Description	Single administration of Ioforminol 160mgI/mL given to the subject. Ioforminol 160 mgI/mL: Given as s single administration to the subject	Given as a single administration to the subject Ioforminol 200 mgI/mL: Given as a single administration to the subject	Given as a single administration to the subject Iopamidol 300 mgI/mL: Given as a single administration to the subject
Period Title: Overall Study
STARTED	30	30	6
COMPLETED	30	30	6
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg	Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg	Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg	Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg	Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg	Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg	Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg	Total
Arm/Group Description	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg.	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg	Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg	Total of all reporting groups
Overall Participants	10	10	10	10	10	10	6	66
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	10 100%	10 100%	10 100%	10 100%	6 100%	66 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 50%	4 40%	4 40%	7 70%	8 80%	5 50%	2 33.3%	35 53%
Male	5 50%	6 60%	6 60%	3 30%	2 20%	5 50%	4 66.7%	31 47%
Region of Enrollment (Number) [Number]
United States	10 100%	10 100%	10 100%	10 100%	10 100%	10 100%	6 100%	66 100%

Outcome Measures

1. Primary Outcome

Title	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).
Description	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.

Outcome Measure Data

Analysis Population Description

Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray.

Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg	Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg	Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg	Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg	Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg	Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg	Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
Arm/Group Description	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg.	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg	Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg
Measure Participants	5	5	5	5	5	5	3
Mean (Standard Deviation) [Hounsfield Units]	168 (41.0)	261 (56.5)	345 (30.7)	341 (33.6)	357 (30.1)	365 (67.7)	331 (53.7)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP).

Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg	Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg	Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg	Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg	Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg	Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg	Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
Arm/Group Description	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg.	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg	Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg
Measure Participants	10	10	10	10	10	10	6
Any Treatment Emergent Adverse Events (TEAE)	3	5	13	8	5	7	5
Any Treatment Emergent Adverse Events-IMP	2	5	13	8	5	7	5
Intensity-Mild	3	5	13	8	5	7	5
Serious TEAEs	0	0	0	0	0	0	0
Withdrawals due to Adverse Events	0	0	0	0	0	0	0
Deaths	0	0	0	0	0	0	0

3. Primary Outcome

Title	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).
Description	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.

Outcome Measure Data

Analysis Population Description

Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube.

Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg	Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg	Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg	Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg	Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg	Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg	Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
Arm/Group Description	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg.	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg.	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg	Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg	Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg
Measure Participants	5	5	5	5	5	5	3
Mean (Standard Deviation) [Hounsfield Units]	191 (34.6)	230 (40.2)	212 (22.2)	261 (37.7)	246 (36.6)	240 (49.4)	257 (9.5)

Adverse Events

Time Frame	Up to 72 hours post Ioforminal or Iopamidol administration.
Arm/Group Title	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg		Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg		Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg		Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg		Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg		Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg		Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
Arm/Group Description	Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg.		Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg.		Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg.		Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg		Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg		Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg		Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg
All Cause Mortality
	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg		Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg		Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg		Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg		Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg		Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg		Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg		Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg		Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg		Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg		Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg		Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg		Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg		Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg		Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg		Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg		Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg		Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg		Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/10 (30%)		5/10 (50%)		10/10 (100%)		8/10 (80%)		5/10 (50%)		7/10 (70%)		5/6 (83.3%)
General disorders
Nausea	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/6 (0%)	0
Feeling Hot	0/10 (0%)	0	1/10 (10%)	1	2/10 (20%)	2	1/10 (10%)	1	2/10 (20%)	2	1/10 (10%)	1	5/6 (83.3%)	5
Musculoskeletal and connective tissue disorders
Back Pain	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/6 (0%)	0
Pain in Extremity	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/6 (0%)	0
Nervous system disorders
Dysgeusia	1/10 (10%)	1	5/10 (50%)	5	9/10 (90%)	9	7/10 (70%)	7	5/10 (50%)	5	5/10 (50%)	5	2/6 (33.3%)	2
Headache	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	1/6 (16.7%)	1
Skin and subcutaneous tissue disorders
Blister	0/10 (0%)	0	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/6 (0%)	0
Dermatitis	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/6 (0%)	0
Erythema	1/10 (10%)	1	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/6 (0%)	0
Rash	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	0/10 (0%)	0	2/10 (20%)	2	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.