Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

• Sponsor: Guerbet (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00980681
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease	Drug: Dotarem; Other: Time of Flight	Phase 3

Detailed Description

Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dotarem Each subject will receive one injection of Dotarem 0.2ml/kg.	Drug: Dotarem; Each subject will receive one injection of Dotarem 0.2ml/kg; Other Names: gadoteric acid, gadoterate meglumine
Other: Time Of Flight Each subject will undergo a TOF Magnetic Resonance Angiography	Other: Time of Flight; Each subject will undergo a TOF MRA

Outcome Measures

Primary Outcome Measures

1. Percent of Non Assessable Renal Artery Segments [1 to 7 days]

   For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female, aged more than 18 years

• Strongly suspected of having renal arterial disease

• Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria:

• Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²)

• Contraindication to MRI

• Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guerbet LLC	Bloomington	Indiana	United States	47403

Sponsors and Collaborators

• Guerbet

Investigators

• Study Director: Pierre DESCHE, MD, Guerbet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guerbet
• ClinicalTrials.gov Identifier: NCT00980681
• Other Study ID Numbers: DGD-44-047
• First Posted: Sep 21, 2009
• Last Update Posted: May 26, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Guerbet: Renal disease; Contrast agent; MRA
• Additional relevant MeSH terms: Kidney Diseases; Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate

Study Results

Participant Flow

Recruitment Details	The recruitment started in Sept 2009 and stopped in February 2010. Radiology departments from hospital or private practices were participating.
Pre-assignment Detail	Out of the 13 enrolled patients, three did not receive treatment, mainly due to the Sponsor decision to interrupt the study

Arm/Group Title	TOF Followed by Dotarem-enhanced MRA
Arm/Group Description	Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
Period Title: TOF MRA
STARTED	10
COMPLETED	10
NOT COMPLETED	0
Period Title: TOF MRA
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	TOF Followed by Dotarem-enhanced MRA
Arm/Group Description	Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 53.8%
>=65 years	6 46.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (16)
Sex: Female, Male (Count of Participants)
Female	9 69.2%
Male	4 30.8%
Region of Enrollment (participants) [Number]
United States	7 53.8%
Canada	6 46.2%

Outcome Measures

1. Primary Outcome

Title	Percent of Non Assessable Renal Artery Segments
Description	For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Time Frame	1 to 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dotarem-enhanced MRA	Time-Of-Flight MRA
Arm/Group Description	Patients benefiting from an MRA after administration with Dotarem	Patients benefiting from an MRA with no injection of contrast medium
Measure Participants	10	10
Number [percentage of non-assessable segments]	25	20

Adverse Events

Arm/Group Title	Dotarem		Time Of Flight
Arm/Group Description	Each subject will receive one injection of Dotarem 0.2ml/kg. Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg		Each subject will undergo a TOF Magnetic Resonance Angiography Time of Flight: Each subject will undergo a TOF MRA
All Cause Mortality
	Dotarem		Time Of Flight
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dotarem		Time Of Flight
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Dotarem		Time Of Flight
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/10 (40%)		0/10 (0%)
Gastrointestinal disorders
Abdominal pain	1/10 (10%)	1	0/10 (0%)	0
Diarrhea	1/10 (10%)	1	0/10 (0%)	0
General disorders
Injection site pain	2/10 (20%)	2	0/10 (0%)	0
Injection site inflammation	1/10 (10%)	1	0/10 (0%)	0

Limitations/Caveats

The study was not completed due to poor enrolment. The statistical analysis was not perfomed.

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.