A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications

• Sponsor: Guerbet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00347022
• Collaborator: (none)
• Enrollment: 145
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Imaging	Drug: Xenetix; Drug: Visipaque	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 145 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Study Start Date: May 1, 2006
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xenetix The patient receive one injection of Xenetix 300 (300 mg of iodine/ml)	Drug: Xenetix; 300 mg of iodine/ml
Active Comparator: Visipaque The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)	Drug: Visipaque; 270 mg of iodine/ml

Outcome Measures

Primary Outcome Measures

1. Creatinine Clearance [between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration]

   The variation of creatinine clearance before and after the product injection was measured

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Child aged 1 year or above and 16 years or under

• Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2)

• Patient requiring MSCT with contrast medium injection for diagnosis

• Patient who has a blood sample planned in the 24 hours preceding the MSCT scan

• Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.

• Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.

• Patient with national health insurance

Exclusion Criteria:

• Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.

• Patient with known allergy to iodinated contrast agent.

• Patient treated with nephrotoxic drugs within one week before first blood sample

• Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)

• Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.

• Breast feeding patient.

• Pregnant patient.

• Patient already included in this trial

• Patient included in another clinical trial involving an investigational drug.

• Patients whose degree of cooperation is incompatible with carrying out the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Charles Nicolle	Rouen		France	76031

Sponsors and Collaborators

• Guerbet

Investigators

• Study Chair: Corinne Dubourdieu, PhD, Guerbet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT00347022
• Other Study ID Numbers: ISO-44-008
• First Posted: Jul 4, 2006
• Last Update Posted: Apr 9, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Guerbet: Multislice computed tomography (MSCT)indications

Study Results

Participant Flow

Recruitment Details	First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)
Pre-assignment Detail	Any patient having a creatinine clearance < 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial

Arm/Group Title	Xenetix	Visipaque
Arm/Group Description	Patient will receive one injection of Xenetix 300	Patient will receive one injection of Visipaque 270
Period Title: Overall Study
STARTED	74	71
COMPLETED	62	66
NOT COMPLETED	12	5

Baseline Characteristics

Arm/Group Title	Xenetix	Visipaque	Total
Arm/Group Description	Patient will be injected with Xenetix 300	Patient will be injected with Visipaque 270	Total of all reporting groups
Overall Participants	74	71	145
Age (Count of Participants)
<=18 years	74 100%	71 100%	145 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.7 (4.8)	8.1 (4.7)	8.4 (4.7)
Sex: Female, Male (Count of Participants)
Female	31 41.9%	28 39.4%	59 40.7%
Male	43 58.1%	43 60.6%	86 59.3%
Region of Enrollment (participants) [Number]
France	59 79.7%	56 78.9%	115 79.3%
Austria	15 20.3%	15 21.1%	30 20.7%

Outcome Measures

1. Primary Outcome

Title	Creatinine Clearance
Description	The variation of creatinine clearance before and after the product injection was measured
Time Frame	between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Xenetix	Visipaque
Arm/Group Description	Patient will receive one injection of Xenetix 300	Patient will receive one injection of Visipaque 270
Measure Participants	62	66
Mean (Standard Deviation) [percent change]	1.1 (19.7)	1.9 (22.0)

Adverse Events

Arm/Group Title	Xenetix		Vispaque
Arm/Group Description	Patient will be injected with Xenetix 300		Patient will be injected with Visipaque 270
All Cause Mortality
	Xenetix		Vispaque
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Xenetix		Vispaque
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/74 (6.8%)		4/71 (5.6%)
Blood and lymphatic system disorders
Myelofibrosis	1/74 (1.4%)	1	0/71 (0%)	0
General disorders
Inflammatory syndrome	1/74 (1.4%)	1	0/71 (0%)	0
Nervous system disorders
Meningitis	0/74 (0%)	0	1/71 (1.4%)	1
Pyramidal syndrom	1/74 (1.4%)	1	0/71 (0%)	0
Respiratory, thoracic and mediastinal disorders
Operation of the mediastinal haematoma	1/74 (1.4%)	1	0/71 (0%)	0
Surgical and medical procedures
Surgery of vesical wound	0/74 (0%)	0	1/71 (1.4%)	1
Ent surgery	0/74 (0%)	0	1/71 (1.4%)	1
Mastoidectomy	0/74 (0%)	0	1/71 (1.4%)	1
Abdominal operation	1/74 (1.4%)	1	0/71 (0%)	0
Other (Not Including Serious) Adverse Events
	Xenetix		Vispaque
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/74 (14.9%)		13/71 (18.3%)
Gastrointestinal disorders
Vomiting	0/74 (0%)	0	2/71 (2.8%)	2
Diarrhoea	0/74 (0%)	0	1/71 (1.4%)	1
Nausea	0/74 (0%)	0	1/71 (1.4%)	1
General disorders
Fever	1/74 (1.4%)	1	2/71 (2.8%)	2
Extravasation	1/74 (1.4%)	1	0/71 (0%)	0
Oedema neck and face	1/74 (1.4%)	1	0/71 (0%)	0
Warmth at the site of injection	0/74 (0%)	0	1/71 (1.4%)	1
Infections and infestations
Gastroenteritis	0/74 (0%)	0	1/71 (1.4%)	1
Tracheitis	1/74 (1.4%)	1	0/71 (0%)	0
Pharyngitis	1/74 (1.4%)	1	0/71 (0%)	0
Investigations
Increase of creatinine	4/74 (5.4%)	4	7/71 (9.9%)	7
Nervous system disorders
Headache	1/74 (1.4%)	1	1/71 (1.4%)	1
Leukoencephalopathy	0/74 (0%)	0	1/71 (1.4%)	1
Vagal discomfort	1/74 (1.4%)	1	0/71 (0%)	0
Skin and subcutaneous tissue disorders
Pruritus	1/74 (1.4%)	1	0/71 (0%)	0
Allergic cutaneous reaction	0/74 (0%)	0	1/71 (1.4%)	1
Cutaneous eruption	2/74 (2.7%)	2	0/71 (0%)	0
Red papules on the arm	1/74 (1.4%)	1	1/71 (1.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Draft of publication to be submitted by the coordinating investigator (no more than 6 months after getting study results) to sponsor and other investigators for review at least 1 month before the submission to the scientific review. Comments to be reviewed and approved by the coordinating investigator and sponsor. Each investigator agrees not to publish the comparison of the renal tolerance involving only the patients he/she has included.